iVue
Device Facts
| Record ID | K163475 |
|---|---|
| Device Name | iVue |
| Applicant | Optovue, Inc. |
| Product Code | OBO · Ophthalmic |
| Decision Date | Jun 9, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1570 |
| Device Class | Class 2 |
Intended Use
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database, the iVue is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Device Story
iVue is a spectral domain-optical coherence tomography (SD-OCT) system for imaging and measuring anterior and posterior ocular structures. Input: OCT signals captured via scanner head; joystick/chinrest assembly aligns scanner with patient eye. Transformation: Software processes signals to generate cross-sectional and 3D images; automated segmentation algorithms calculate thickness of corneal epithelia, stroma, and total pachymetry. Output: High-resolution tomographic images and quantitative thickness maps displayed on PC monitor. Used in clinical settings by eye care professionals. Healthcare providers use output to compare patient measurements against an integrated normative database, aiding diagnosis and management of ocular conditions. Benefits include automated, repeatable, and reproducible corneal layer measurements, reducing reliance on manual caliper-based analysis.
Clinical Evidence
Two clinical studies conducted. 1) Repeatability and Reproducibility (R&R) study: 59 subjects (normal and corneal patients) evaluated using crossed-study design/ANOVA. Demonstrated good repeatability/reproducibility for pachymetry, epithelial, and stromal thickness across all groups. 2) Agreement study: 87 subjects (normal and corneal patients) compared automated software output to manual caliper measurements. Mean differences were <0.7 µm (epithelial), <1.9 µm (stromal), and <2.3 µm (pachymetry), indicating negligible difference and good agreement between methods.
Technological Characteristics
Spectral domain-OCT system; scanner head, computer (laptop/AIO), control box, joystick/chinrest. Connectivity: USB 3.0 (camera), Ethernet. Software: Automated segmentation algorithm for corneal layers. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 62304 (software lifecycle), EN ISO 14971 (risk management).
Indications for Use
Indicated for adult population to aid in diagnosis, documentation, and management of ocular health and diseases via non-contact, high-resolution tomographic imaging and measurement of anterior/posterior ocular structures (retina, RNFL, GCC, optic disc, cornea, corneal epithelia, corneal stroma, anterior chamber).
Regulatory Classification
Identification
An ophthalmoscope is an AC-powered or battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye.
Special Controls
*Classification.* Class II (special controls). The device, when it is an AC-powered opthalmoscope, a battery-powered opthalmoscope, or a hand-held ophthalmoscope replacement battery, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Predicate Devices
- iVue with Normative Database (K121739)
Related Devices
- K121739 — IVUE WITH NORMATIVE DATABASE · Optovue, Inc. · Jan 18, 2013
- K083291 — CIRRUS HD-OCT WITH RETINAL NERVE FIBER LAYER AND MACULAR NORMATIVE DATABASES, MODEL 4000 · Carl Zeiss Meditec, Inc. · May 5, 2009
- K091404 — IVUE, MODEL 100 · Optovue, Inc. · Apr 22, 2010
- K133892 — IVUE 500 · Optovue, Inc. · Mar 19, 2014
- K100861 — R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 · Optovue, Inc. · Jun 17, 2010
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 9, 2017
Optovue, Inc. Edward J. Sinclair Vice President, Regulatory and Quality Affairs 2800 Bayview Drive Fremont, CA 94538
Re: K163475
Trade/Device Name: iVue Regulation Number: 21 CFR 886.1570 Regulation Name: Ophthalmoscope Regulatory Class: Class II Product Code: OBO, HLI Dated: May 5, 2017 Received: May 8, 2017
Dear Edward J. Sinclair:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known)
K163475
Device Name
iVue
Indications for Use (Describe)
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in-vivo imaging, axial crosssectional, and three-dimensional imaging and measurement of anterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database, the iVue is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
Type of Use (Select one or both, as applicable)
| <div> <span> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" stroke-width="1" width="15"></rect> <line stroke="black" stroke-width="2" x1="0" x2="15" y1="0" y2="15"></line> <line stroke="black" stroke-width="2" x1="0" x2="15" y1="15" y2="0"></line> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> <svg height="15" width="15"> <rect fill="white" height="15" stroke="black" stroke-width="1" width="15"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image contains the logo for Optovue. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the word is a circular graphic that is colored with an orange gradient.
### 510(k) SUMMARY
### Submitter Information
| Company: | Optovue, Inc.<br>2800 Bayview Drive<br>Fremont, CA 94538<br>Phone: (510) 623-8868<br>Fax: (510) 651-2516<br>Est. Registration No.: 3005950902 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Edward J. Sinclair<br>Vice President, Regulatory and Quality Affairs<br>Phone: (510) 897-1575<br>Fax: (510) 651-2516 |
| Date Prepared: | June 8, 2017 |
### Device Name and Classification
| Common Name: | Optical Coherence Tomography System |
|----------------------|-------------------------------------|
| Proprietary Name: | iVue |
| Classification Name: | Tomography, Optical Coherence |
| Product Code: | OBO, HLI |
| Regulation Number: | 21 CFR§ 886.1570 |
| Device Class: | II |
### Predicate Device
| Company: | Optovue, Inc. |
|----------|----------------------------------------|
| Device: | iVue with Normative Database (K121739) |
### Intended Use
The iVue is an optical coherence tomography system intended for in vivo imaging, axial crosssectional, three-dimensional imaging and measurement of anterior and posterior ocular
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic that transitions in color from yellow to orange to red. The logo is simple and modern.
structures. There is no change in the intended use between the predicate i Vue device and the modified i Vue device that is the subject of this submission.
### Indications For Use
Optovue has updated the iVue indications for use based on the modified ability of the software to determine the corneal epithelia and stroma layer thickness. The epithelia and stroma have been added to the current list of ocular structures that can be imaged by the iVue device. The complete, updated indication statement is provided below:
The iVue is a non-contact, high resolution tomographic imaging device. It is intended for in vivo imaging, axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures, including retina, retinal nerve fiber layer, ganglion cell complex (GCC), optic disc, cornea, corneal epithelia, corneal stroma and anterior chamber of the eye. With the integrated normative database. the iVue is a quantitative tool for the comparison of retina, retinal nerve fiber layer, ganglion cell complex, and optic disc measurements to a database of known normal subjects. The iVue is indicated for use as a device to aid in the diagnosis, documentation, and management of ocular health and diseases in the adult population.
### Device Description
The iVue is used to capture, store, display and print spectral domain-optical coherence tomography (SD-OCT) images of the posterior and anterior structure of the eye. The device software includes a Normative Database (NDB), consisting of OCT data from a range of known normal subjects that can be used to compare a new patient's measurements in relation to the normal distribution.
iVue is a computer-controlled ophthalmic imaging system using either a laptop computer or "All-in-One" computer. For laptop systems there are two control box options of 120 or 230 volts. The control box interfaces between the motorized table column and the medical-grade power supply for the computer.
#### iVue System Key Functional Components
The iVue system contains the following hardware components:
- . Scanner Head: the scanner is the main component of the iVue system. It is used to view and scan the patient's eye, collect the OCT signal, and send it to the computer for processing.
- . Computer: the system computer, either a laptop or All-in-One ("AIO"), which includes the computer and monitor in one unit), is approved for medical use. It supports scanner operation and processes, stores and displays exam data through the application software. The searchable iVue database stores and organizes patient and exam data.
- . Control Box: the control box supports operation of the scanner and contains the backup hard disk.
- Joystick and Chinrest Assembly: the joystick moves the scanner left and right, forward and back, and aligns it with the patient's eye to capture the scan.
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a sans-serif font, with the letters in a light gray color. To the left of the word is a circular graphic that is colored with a gradient, transitioning from orange at the bottom to yellow at the top. The logo is simple and modern in design.
- . Footswitch (optional): the footswitch provides another way to capture scans, including autoadjustment, capture and saving.
- . Motorized Table (optional): a motorized table is optional. Customers may order the table in two input voltages of 120V or 230V.
- . Cornea Adapter Module: the cornea lens adapter is attached to the front of the instrument to enable the iVue to image the cornea and anterior chamber of the eye.
#### Comparison of Technological Characteristics with the Predicate Device
The iVue with modified software is substantially equivalent to the iVue predicate device (cleared by FDA in K121739 on January 18, 2013). The intended use, mechanism of action, subassemblies, and key components remain the same. The modified software uses equivalent optical coherence tomography and segmentation technology as the predicate. The iVue device has been updated in the following ways:
- 1. A software modification allows automated segmentation of the posterior corneal epithelium boundary to provide the thickness of the epithelial layer. This capability, in conjunction with previously-cleared full cornea thickness measurement (i.e., "pachymetry"), also allows the software to automatically calculate the thickness of the stroma layer. Previously, the thickness of the epithelial and stroma layers could be manually measured using digital calipers in the iVue software. Consequently, the proposed software changes will automate the manual process of measuring the corneal epithelium and stroma layer thickness that could be performed using the previously cleared iVue software and provide color thickness "maps" of those layers.
- 2. There were several changes to the iVue device that did not require 510(k) premarket clearance when made. These include changing the Line Scan Camera communication from gigabit Ethernet to USB 3. removal of redundant LCD monitor from the scanner head. addition of an "All-in-One" computer option, support for Windows 7 operating system, updated reports and other minor software changes.
#### Risk Analysis
The risk management process at Optovue complies with EN ISO 14971:2012 "Medical devices -- Application of risk management to medical devices." As required by this standard, risk analyses are conducted according to defined procedures, using experienced, qualified personnel from multiple functions throughout the organization with prior experience in risk assessment.
The i Vue Hazard Analysis was updated by the same qualified personnel who re-assessed the device with respect to all changes. Potential hazards were mitigated through the device design, software controls and user instructions and any mitigations were subsequently verified and validated. All of the identified hazards were mitigated to an acceptable level of risk. The potential benefits to patients outweigh the low residual risk after modifying the iVue software to enable automated thickness measurement of the corneal epithelia and stroma layers.
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the logo for Optovue. The logo consists of a stylized circle that transitions from orange to yellow on the left side. To the right of the circle is the word "OPTOVUE" in a sans-serif font. The text is a light gray color.
### Performance Data
The following performance data were provided in support of the substantial equivalence determination:
Electrical Safety and Electromagnetic Compatibility (EMC) The iVue device has been tested according to IEC 60601-1 and IEC 60601-1-2 standards and was found to meet all requirements.
### Software Verification and Validation Testing
Device software was verified and validated to support the indications for use according to IEC 62304:2006 "Medical device software – Software life cycle processes" and FDA's "General Principles of Software Validation: Final Guidance for Industry and FDA Staff." In accordance with the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005," documentation was provided that demonstrates the software changes performed as intended, met acceptance criteria, and did not have a negative impact on product performance, overall product safety, or patient safety.
The software for this device was determined to be a "moderate" level of concern, since a malfunction of, or a latent design flaw in the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury. There was no change in the level of concern from the predicate iVue device.
Two clinical studies were performed to evaluate the repeatability and reproducibility and agreement to manual measurement of the iVue pachymetry scan for the corneal thickness (pachymetry), corneal epithelial thickness, and corneal thickness mapping in normal subjects and corneal patients. Overall, the studies showed good repeatability and reproducibility for all study groups, all map zones, and for all 3 parameters evaluated and analyses demonstrating agreement of the automated corneal epithelial thickness segmentation.
#### Clinical Evaluation
Two clinical studies were conducted to demonstrate substantial equivalence:
### 1. Clinical Study for Repeatability and Reproducibility (R&R) of Corneal Epithelial Thickness Mapping with iVue SD-OCT
The objective of this clinical study was to evaluate the repeatability and reproducibility of the modified iVue software for the corneal thickness (pachymetry), the epithelial thickness, and the stromal thickness mapping using the ETM 6mm scan in normal subjects and corneal patients based on a crossed-study design and crossed random-effects ANOVA model.
A heterogeneous population of qualified study subjects was evaluated and included a Normal Subjects group (12 subjects), a Corneal Patients group (47 subjects) further stratified into 4 subgroups: Contact Lens (12 subiects). Drv Eve (11 subjects). Post-Refractive Surgerv (LRS) (12 subjects), and Keratoconus (KCN) (12 subjects). The study inclusion criteria required subjects who were 18 years of age or older, able to provide consent, and were
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic that transitions from orange to yellow. The logo is simple and modern.
willing to complete the required examinations. In addition, subjects were qualified based on a history or clinical diagnosis of one or more of the following conditions:
- . Dry eye patients with no history of refractive surgery
- Contact lens patients without complications, refractive surgery or dry eye
- Post-laser refractive surgery patients with 1 month post-surgery without complications ●
- . Keratoconus patients with a clinical diagnosis of keratoconus in the study eye
The study exclusion criteria excluded those with the inability to complete the required SD-OCT scans (e.g., unable to fixate due to poor vision).
Three iVue devices were used. The same scanning protocol with device-specific designated operator was implemented to scan each qualified subject on 3 different devices, with 3 repeated epithelial thickness scans per device. Based on a crossed-study design, each study subject was imaged with all three iVue/operator pairs, and within each iVue/operator pair, at least three scans were acquired with the operator realigning the instrument on the study eve for each scan acquisition. To ensure realignment for each scan, the operator asked the test subject to sit back after a scan acquisition and then reposition for the next scan.
The evaluated ETM 6 mm scan showed good performance across all study groups in terms of ease of acquisition (no subjects excluded due to inability to perform the scan quality.
Seventy-one out of 598 total acquired scans (11.9%) were excluded from R&R analysis due to the following scan quality issues: decentration of the scan, eyelid artifacts, cropped OCT image, low SSI and motion artifacts. The percentage of disqualified scans was similar across Normal eyes (10.7%) and Corneal Patients eyes (12.1%). The distribution of non-qualifying scans across three different device/operator pairs was also similar: 20/194 (10.3%). 23/199 (11.6%) and 28/205 (13.6%) accordingly for iVue #24220. iVue #20847 and iVue #20779.
Out of 527 scans qualified for final analysis, 40 (7.6%) required manual edits of the segmentation lines. Manual edits were not required in Normal eyes scans, and ranged from 2.8% in Contact Lens sub-group to 17.9% in KCN sub-group, with similar distribution between the 3 iVue devices. For qualified scans, the operators reviewed the thickness maps for obvious segmentation error and reviewed the individual corneal meridian images to verify segmentation for erroneous maps. Segmentation edit tools were used to perform manual correction and then the epithelial map was reprocessed. Noticeable segmentation errors were manually corrected by the operator and marked for "Manual Correction" in the case report form. Scans with manual correction qualified for R&R data analysis.
A total of 59 subjects included in the data analysis had a demographic distribution by ethnicity that was majority Caucasian (40.7%), followed by Asian (25.4%), Hispanic (20.3%), African American (8.5%), and Other/Combined (5.1%). There was fair distribution of gender with 25 (42%) male and 34 (58%) female subjects enrolled.
Age distribution of Normal and Corneal Patient groups and subgroups is listed in table below. Age distribution was similar in Normal vs Corneal Patient group (total).
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image contains the logo for Optovue. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic that transitions in color from yellow to orange. The logo is simple and clean, with a focus on the company name.
| Age by Category | Min | Median | Mean | Max | SD |
|-------------------------------------|-----|--------|------|-----|------|
| Normal | 18 | 43 | 42 | 63 | 15.7 |
| Corneal Patients (total) | 18 | 40 | 45 | 79 | 16.9 |
| Contact Lens Group | 20 | 36 | 38 | 58 | 10.8 |
| Dry Eye Group | 30 | 62 | 57 | 79 | 18.8 |
| Post Laser Refractive Surgery Group | 30 | 47 | 50 | 78 | 18.7 |
| Keratoconus Group | 19 | 36 | 39 | 63 | 14.7 |
Age distribution for all subjects by enrollment Category.
### Corneal Patients Study Group Characterization
| Contact Lens Group | |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | All subjects in the Contact Lens group wore soft contact lens regularly for 8 or<br>more hours per day and for at least 3 months at the time of enrollment. The<br>duration and the daily wear of contact lens are summarized below. |
Contact lens wear data for the Contact Lens study group.
| Contact Lens Wear | Min | Median | Mean | Max | SD |
|-------------------|-----|--------|------|-----|-----|
| Duration (years) | 2 | 11 | 11 | 20 | 6.3 |
| Hours/Day | 8 | 11 | 12 | 18 | 3.6 |
| Dry Eye Group | For the Dry Eye group, the severity of the dry eye condition for each study<br>subject was documented using Ocular Surface Disease Index (OSDI) score with a |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | scale from 0 to 100 (mild to severe) and Tear Break Up Time (TBUT). The |
| | distribution of the OSDI score and TBUT for this group are summarized below. |
OSDI Score and Tear Break Up Time (TBUT) distribution of the Dry Eye study group.
| Dry Eye | Min | Median | Mean | Max | SD |
|----------------|------|--------|------|------|------|
| ODSI Score | 14.6 | 54.5 | 48.8 | 83.3 | 21.5 |
| TBUT (seconds) | 1 | 7 | 7 | 10 | 3 |
| Post-LRS Group | For the Post LRS group, the majority (75%) had LASIK procedure versus the PRK procedure (25%), mainly for myopic vision correction (83.3%) and most had the procedure done at least 1 year or more prior to testing (91.7SD of 3.9108 scans%). The summary details are shown in Table below. |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image contains the logo for Optovue. The logo features the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic with a gradient of orange and yellow. The graphic appears to be a stylized representation of an eye or lens.
| Procedure | Total | % Total |
|--------------------------|-------|---------|
| LASIK | 9 | 75 |
| PRK | 3 | 25 |
| Correction | Total | % Total |
| Myopic | 10 | 83.3% |
| Hyperopic | 1 | 8.3% |
| Astigmatism | 1 | 8.3% |
| Duration since procedure | | |
| > 1yr | 11 | 91.7% |
| > 3mo | 1 | 8.3% |
#### Clinical data for Post LRS study group
| KCN Group | The subjects in the KCN group all had clinical diagnosis of keratoconus. The clinical signs and severity of keratoconus for the study group are summarized in Table 7.5.4a and further details on corneal curvature are summarized in Table 7.5.4b. In addition to one subject had INTACS implant, we identified another subject in the KCN sub-group had PK (penetrating keratoplasty) five years prior to the study visit in the study eye. There were no other surgical treatments in the study eyes. (i.e., Cross linking) |
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
KCN group distribution by clinical signs and severity
| Clinical Signs | Total | % Total |
|---------------------------------------|-------|---------|
| Slit lamp exam | 7 | 58.3% |
| Topographic patterns | 11 | 91.7% |
| Slit lamp exam & Topographic patterns | 6 | 50% |
| Retinoscope reflex | 2 | 16.7% |
| Severity | Total | % Total |
| Mild | 2 | 16.7% |
| Moderate | 8 | 66.7% |
| Severe* | 2 | 16.7% |
Distribution of Steep K and Delta K (difference between Steep K and Flat K) in KCN group.
| Corneal Curvature | Min | Median | Mean | Max | SD |
|-------------------|------|--------|------|-----|-----|
| Steep K | 42.1 | 49 | 48.1 | 54 | 3.9 |
| Delta K | 0.6 | 2.3 | 2.4 | 4.3 | 1.1 |
Summary statistical parameters, including the mean, standard deviation (SD), range (minimum and maximum), Repeatability SD, Reproducibility SD, Reproducibility covariance (COV) and Reproducibility Limit for pachymetry, epithelial thickness and stromal thickness for Normal Patients, Corneal Patients, and Corneal Patient study subgroups is provided in the following tables. Repeatability standard deviation was similar to the Reproducibility standard deviation for all study parameters and therefore is not detailed separately in the summary tables below.
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the logo for Optovue. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic that transitions from orange to yellow. The logo is simple and modern.
# Pachymetry
| Normal Group (N scans=108) | | | | | | | | |
|----------------------------|-------|------|-------|-------|---------------------|-----------------------|------|--------|
| | Mean | SD | Min | Max | Repeatability<br>SD | Reproducibility<br>SD | COV | Limit* |
| Zonal Parameters | | | | | | | | |
| C_2_Pachy | 538.1 | 19.4 | 506.8 | 588.4 | 1.7 | 2.2 | 0.4% | 6.0 |
| T_2_5_Pachy | 546.3 | 22.5 | 503.2 | 604.4 | 2.8 | 2.9 | 0.5% | 8.0 |
| ST_2_5_Pachy | 564.0 | 23.2 | 528.4 | 628.5 | 3.7 | 3.9 | 0.7% | 10.9 |
| S_2_5_Pachy | 577.3 | 22.4 | 542.1 | 642.6 | 4.4 | 4.7 | 0.8% | 12.9 |
| SN_2_5_Pachy | 576.0 | 21.3 | 543.4 | 644.1 | 5.1 | 5.1 | 0.9% | 14.2 |
| N_2_5_Pachy | 563.0 | 21.4 | 532.5 | 630.3 | 3.8 | 3.8 | 0.7% | 10.6 |
| IN_2_5_Pachy | 551.6 | 20.2 | 520.0 | 607.0 | 2.3 | 2.7 | 0.5% | 7.4 |
| I_2_5_Pachy | 544.1 | 19.7 | 506.4 | 592.5 | 2.1 | 2.7 | 0.5% | 7.5 |
| IT_2_5_Pachy | 540.3 | 21.1 | 499.7 | 590.4 | 2.1 | 2.3 | 0.4% | 6.4 |
| T_5_6_Pachy | 565.1 | 25.0 | 512.9 | 631.2 | 3.8 | 3.9 | 0.7% | 10.7 |
| ST_5_6_Pachy | 593.4 | 24.8 | 553.7 | 667.6 | 5.6 | 5.8 | 1.0% | 16.0 |
| S_5_6_Pachy | 613.9 | 23.8 | 573.7 | 685.3 | 6.3 | 6.8 | 1.1% | 18.7 |
| SN_5_6_Pachy | 609.1 | 23.6 | 570.6 | 685.9 | 7.6 | 7.7 | 1.3% | 21.3 |
| N_5_6_Pachy | 589.4 | 24.3 | 550.3 | 666.2 | 5.2 | 5.2 | 0.9% | 14.5 |
| IN_5_6_Pachy | 573.4 | 22.9 | 538.4 | 635.3 | 3.7 | 3.7 | 0.7% | 10.4 |
| I_5_6_Pachy | 564.7 | 22.1 | 523.2 | 621.0 | 3.3 | 3.5 | 0.6% | 9.8 |
| IT_5_6_Pachy | 557.1 | 24.0 | 508.5 | 616.4 | 3.8 | 3.8 | 0.7% | 10.6 |
### Table 1a. Pachymetry measurements - Normal group
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image contains the logo for Optovue. The logo consists of a circular graphic on the left, with the word "OPTOVUE" in capital letters to the right of the circle. The circle has a gradient of orange and yellow. The text is in a light gray color.
| Corneal Patients Group (Pooled) (N scans=419) | | | | | | | | |
|-----------------------------------------------|-------|------|-------|-------|---------------|-----|-----------------|--------|
| | Mean | SD | Min | Max | Repeatability | | Reproducibility | |
| | | | | | SD | SD | COV | Limit* |
| Zonal Parameters | | | | | | | | |
| C_2_Pachy | 507.5 | 49.2 | 389.4 | 678.7 | 3.3 | 3.6 | 0.7% | 10.0 |
| T_2_5_Pachy | 521.3 | 46.4 | 415.6 | 694.7 | 3.8 | 3.8 | 0.7% | 10.6 |
| ST_2_5_Pachy | 541.2 | 46.6 | 439.5 | 717.9 | 4.7 | 4.8 | 0.9% | 13.2 |
| S_2_5_Pachy | 554.3 | 47.2 | 445.1 | 726.2 | 5.3 | 5.4 | 1.0% | 15.0 |
| SN_2_5_Pachy | 551.3 | 46.1 | 445.1 | 723.0 | 5.7 | 5.8 | 1.0% | 16.0 |
| N_2_5_Pachy | 538.0 | 44.9 | 439.1 | 704.9 | 5.0 | 5.2 | 1.0% | 14.4 |
| IN_2_5_Pachy | 524.7 | 46.3 | 430.3 | 687.3 | 4.2 | 4.5 | 0.9% | 12.6 |
| I_2_5_Pachy | 513.3 | 50.7 | 404.7 | 679.6 | 3.3 | 3.7 | 0.7% | 10.3 |
| IT_2_5_Pachy | 510.3 | 49.9 | 386.3 | 676.8 | 3.5 | 3.7 | 0.7% | 10.2 |
| T_5_6_Pachy | 545.2 | 44.3 | 443.6 | 719.9 | 5.0 | 5.0 | 0.9% | 14.0 |
| ST_5_6_Pachy | 575.1 | 46.8 | 461.1 | 747.7 | 6.7 | 6.8 | 1.2% | 18.8 |
| S_5_6_Pachy | 595.6 | 48.7 | 478.4 | 757.8 | 8.6 | 8.8 | 1.5% | 24.4 |
| SN_5_6_Pachy | 587.6 | 46.7 | 482.7 | 759.0 | 8.6 | 8.8 | 1.5% | 24.4 |
| N_5_6_Pachy | 568.2 | 43.3 | 473.0 | 733.0 | 6.5 | 6.6 | 1.2% | 18.2 |
| IN_5_6_Pachy | 553.3 | 42.9 | 460.6 | 711.2 | 5.2 | 5.5 | 1.0% | 15.1 |
| I_5_6_Pachy | 540.4 | 47.7 | 444.2 | 707.9 | 5.6 | 5.8 | 1.1% | 15.9 |
| IT_5_6_Pachy | 533.2 | 47.0 | 414.2 | 700.2 | 5.8 | 5.9 | 1.1% | 16.3 |
# Table 1b. Pachymetry measurement – Corneal Patients pooled group
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image contains the logo for Optovue. The logo consists of a circular graphic on the left, with the word "OPTOVUE" in capital letters to the right of the circle. The circle has a gradient of orange and yellow. The text is in a light gray color.
| Contact Lens Group (N scans=108) | | | | | Repeatability | | Reproducibility | | |
|----------------------------------|-------|------|-------|------------------|---------------|--|-----------------|------|--------|
| | Mean | SD | Min | Max | SD | | SD | COV | Limit* |
| | | | | | | | | | |
| | | | | Zonal Parameters | | | | | |
| C_2_Pachy | 513.4 | 40.0 | 425.5 | 589.0 | 1.6 | | 2.1 | 0.4% | 5.9 |
| T_2_5_Pachy | 522.7 | 40.5 | 432.1 | 597.9 | 2.5 | | 2.8 | 0.5% | 7.6 |
| ST_2_5_Pachy | 540.1 | 42.5 | 444.5 | 630.9 | 3.9 | | 3.9 | 0.7% | 10.7 |
| S_2_5_Pachy | 553.6 | 43.5 | 456.2 | 651.0 | 4.7 | | 4.7 | 0.9% | 13.1 |
| SN_2_5_Pachy | 551.4 | 42.1 | 455.4 | 641.8 | 4.7 | | 4.7 | 0.8% | 12.9 |
| N_2_5_Pachy | 538.3 | 40.3 | 449.3 | 620.2 | 3.7 | | 3.7 | 0.7% | 10.2 |
| IN_2_5_Pachy | 527.3 | 39.0 | 444.9 | 596.3 | 2.4 | | 2.7 | 0.5% | 7.6 |
| I_2_5_Pachy | 520.1 | 39.3 | 436.5 | 588.6 | 1.9 | | 2.9 | 0.6% | 7.9 |
| IT_2_5_Pachy | 516.8 | 39.5 | 430.4 | 586.0 | 1.9 | | 2.7 | 0.5% | 7.6 |
| T_5_6_Pachy | 541.4 | 41.7 | 443.6 | 618.7 | 3.7 | | 3.7 | 0.7% | 10.2 |
| ST_5_6_Pachy | 569.4 | 45.7 | 461.1 | 667.1 | 5.4 | | 5.4 | 0.9% | 14.9 |
| S_5_6_Pachy | 591.7 | 47.9 | 481.7 | 700.7 | 7.3 | | 7.4 | 1.2% | 20.4 |
| SN_5_6_Pachy | 585.9 | 44.7 | 483.5 | 688.2 | 7.6 | | 7.8 | 1.3% | 21.7 |
| N_5_6_Pachy | 565.3 | 41.3 | 473.6 | 652.9 | 5.1 | | 5.1 | 0.9% | 14.2 |
| IN_5_6_Pachy | 550.2 | 38.9 | 467.8 | 620.3 | 3.5 | | 3.7 | 0.7% | 10.2 |
| I_5_6_Pachy | 541.8 | 39.9 | 454.5 | 614.6 | 3.4 | | 4.0 | 0.7% | 11.0 |
| IT_5_6_Pachy | 534.1 | 40.5 | 442.4 | 610.3 | 3.5 | | 4.1 | 0.8% | 11.3 |
| | | Table 1c. Pachymetry measurements - Contact Lens group | | ) |
|--|--|--------------------------------------------------------|--|---|
|--|--|--------------------------------------------------------|--|---|
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image contains the logo for Optovue. The logo consists of a circular graphic on the left, with the word "OPTOVUE" in capital letters to the right of the circle. The circle has a gradient of orange and yellow. The text is in a light gray color.
| Dry Eye Group (N scans=98) | | | | | | | | |
|----------------------------|-------|------|-------|-------|---------------|-----------------|------|--------|
| | Mean | SD | Min | Max | Repeatability | Reproducibility | | |
| | | | | | SD | SD | COV | Limit* |
| Zonal Parameters | | | | | | | | |
| C_2_Pachy | 531.7 | 40.6 | 445.6 | 606.0 | 3.4 | 3.8 | 0.7% | 10.5 |
| T_2_5_Pachy | 540.3 | 36.0 | 469.7 | 600.9 | 3.4 | 3.5 | 0.6% | 9.6 |
| ST_2_5_Pachy | 558.3 | 38.7 | 485.4 | 640.9 | 5.2 | 5.2 | 0.9% | 14.5 |
| S_2_5_Pachy | 573.3 | 40.2 | 502.9 | 673.7 | 6.8 | 7.0 | 1.2% | 19.3 |
| SN_2_5_Pachy | 570.3 | 38.0 | 501.5 | 669.3 | 7.4 | 7.7 | 1.3% | 21.3 |
| N_2_5_Pachy | 558.0 | 35.6 | 491.8 | 644.8 | 5.8 | 6.3 | 1.1% | 17.4 |
| IN_2_5_Pachy | 548.9 | 34.2 | 485.9 | 613.0 | 4.1 | 4.8 | 0.9% | 13.3 |
| I_2_5_Pachy | 538.0 | 41.4 | 436.0 | 590.4 | 3.7 | 4.0 | 0.7% | 11.2 |
| IT_2_5_Pachy | 531.8 | 44.1 | 418.3 | 588.6 | 3.7 | 3.7 | 0.7% | 10.3 |
| T_5_6_Pachy | 557.1 | 36.0 | 483.4 | 615.2 | 4.4 | 4.5 | 0.8% | 12.4 |
| ST_5_6_Pachy | 588.9 | 38.8 | 518.4 | 681.9 | 8.8 | 8.8 | 1.5% | 24.4 |
| S_5_6_Pachy | 616.6 | 42.0 | 550.0 | 736.3 | 13.1 | 13.4 | 2.2% | 37.1 |
| SN_5_6_Pachy | 607.0 | 37.6 | 547.3 | 725.0 | 11.6 | 12.1 | 2.0% | 33.4 |
| N_5_6_Pachy | 586.7 | 32.4 | 531.6 | 680.0 | 8.1 | 8.4 | 1.4% | 23.3 |
| IN_5_6_Pachy | 575.0 | 29.9 | 522.1 | 634.0 | 5.1 | 5.5 | 1.0% | 15.3 |
| I_5_6_Pachy | 559.7 | 42.4 | 453.6 | 615.1 | 5.1 | 5.2 | 0.9% | 14.5 |
| IT_5_6_Pachy | 546.4 | 48.4 | 414.2 | 605.3 | 5.4 | 5.4 | 1.0% | 14.9 |
| | | Table 1d. Pachymetry measurements - Dry Eye group | | |
|--|--|---------------------------------------------------|--|--|
|--|--|---------------------------------------------------|--|--|
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image features the logo for Optovue. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic that transitions in color from yellow to orange. The overall design is clean and modern.
| Post Laser Refractive Surgery Group (N scans=107) | | | | | | | | | | |
|---------------------------------------------------|-------|------|-------|-------|---------------|-----------------|------|--------|--|--|
| | Mean | SD | Min | Max | Repeatability | Reproducibility | | | | |
| | | | | | SD | SD | COV | Limit* | | |
| Zonal Parameters | | | | | | | | | | |
| C_2_Pachy | 504.6 | 64.5 | 411.8 | 678.7 | 1.5 | 1.9 | 0.4% | 5.2 | | |
| T_2_5_Pachy | 521.3 | 60.9 | 435.5 | 694.7 | 3.2 | 3.4 | 0.6% | 9.3 | | |
| ST_2_5_Pachy | 538.6 | 63.4 | 439.5 | 717.9 | 4.2 | 4.2 | 0.8% | 11.7 | | |
| S_2_5_Pachy | 552.0 | 63.2 | 445.1 | 726.2 | 4.5 | 4.5 | 0.8% | 12.5 | | |
| SN_2_5_Pachy | 548.0 | 63.1 | 445.1 | 723.0 | 4.9 | 4.9 | 0.9% | 13.7 | | |
| N_2_5_Pachy | 534.9 | 61.6 | 439.1 | 704.9 | 4.3 | 4.4 | 0.8% | 12.3 | | |
| IN_2_5_Pachy | 527.0 | 59.9 | 432.0 | 687.3 | 3.4 | 3.9 | 0.7% | 10.8 | | |
| I_2_5_Pachy | 522.0 | 58.2 | 433.8 | 679.6 | 3.0 | 3.5 | 0.7% | 9.7 | | |
| IT_2_5_Pachy | 516.8 | 57.8 | 433.7 | 676.8 | 2.9 | 3.2 | 0.6% | 8.8 | | |
| T_5_6_Pachy | 548.5 | 58.9 | 464.0 | 719.9 | 4.9 | 5.2 | 0.9% | 14.3 | | |
| ST_5_6_Pachy | 577.0 | 60.7 | 472.5 | 747.7 | 5.7 | 5.9 | 1.0% | 16.2 | | |
| S_5_6_Pachy | 599.0 | 57.7 | 484.3 | 757.8 | 6.3 | 6.4 | 1.1% | 17.7 | | |
| SN_5_6_Pachy | 590.8 | 58.7 | 486.1 | 759.0 | 7.3 | 7.3 | 1.2% | 20.3 | | |
| N_5_6_Pachy | 569.1 | 58.1 | 473.0 | 733.0 | 6.4 | 6.4 | 1.1% | 17.7 | | |
| IN_5_6_Pachy | 558.4 | 56.2 | 460.6 | 711.2 | 5.6 | 5.8 | 1.0% | 16.2 | | |
| I_5_6_Pachy | 553.2 | 54.3 | 465.6 | 707.9 | 4.6 | 4.9 | 0.9% | 13.7 | | |
| IT_5_6_Pachy | 543.0 | 54.1 | 463.1 | 700.2 | 4.7 | 5.0 | 0.9% | 13.7 | | |
# Table 1e. Pachymetry measurements – Post-LRS group
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image contains the logo for Optovue. The logo consists of the word "OPTOVUE" in a sans-serif font, with the letters in a light gray color. To the left of the text is a circular graphic that fades from orange to yellow. The logo is simple and modern in design.
| Keratoconus Group (N scans=106) | | | | | | | | |
|---------------------------------|-------|------|-------|-------|---------------|-----------------|------|--------|
| | Mean | SD | Min | Max | Repeatability | Reproducibility | | |
| | | | | | SD | SD | COV | Limit* |
| Zonal Parameters | | | | | | | | |
| C_2_Pachy | 482.1 | 32.5 | 389.4 | 522.2 | 5.4 | 5.5 | 1.1% | 15.1 |
| T_2_5_Pachy | 502.1 | 35.4 | 415.6 | 544.6 | 5.3 | 5.3 | 1.1% | 14.6 |
| ST_2_5_Pachy | 529.1 | 30.6 | 450.5 | 567.3 | 5.5 | 5.6 | 1.1% | 15.5 |
| S_2_5_Pachy | 539.9 | 29.3 | 463.3 | 576.5 | 4.9 | 5.0 | 0.9% | 14.0 |
| SN_2_5_Pachy | 536.8 | 27.3 | 463.6 | 570.0 | 5.3 | 5.5 | 1.0% | 15.2 |
| N_2_5_Pachy | 522.3 | 27.3 | 453.1 | 563.5 | 6.0 | 6.1 | 1.2% | 16.9 |
| IN_2_5_Pachy | 497.2 | 31.1 | 430.3 | 548.0 | 5.9 | 6.1 | 1.2% | 16.9 |
| I_2_5_Pachy | 474.7 | 38.1 | 404.7 | 533.3 | 4.2 | 4.4 | 0.9% | 12.2 |
| IT_2_5_Pachy | 477.2 | 38.9 | 386.3 | 532.5 | 4.8 | 4.8 | 1.0% | 13.3 |
| T_5_6_Pachy | 534.6 | 32.8 | 461.1 | 574.7 | 6.3 | 6.5 | 1.2% | 17.9 |
| ST_5_6_Pachy | 566.3 | 34.6 | 478.6 | 608.7 | 6.4 | 6.7 | 1.2% | 18.6 |
| S_5_6_Pachy | 576.6 | 36.2 | 478.4 | 623.3 | 6.6 | 6.6 | 1.2% | 18.4 |
| SN_5_6_Pachy | 568.4 | 33.8 | 482.7 | 616.7 | 7.3 | 7.6 | 1.3% | 21.0 |
| N_5_6_Pachy | 553.3 | 28.4 | 480.2 | 588.6 | 6.0 | 6.1 | 1.1% | 17.0 |
| IN_5_6_Pachy | 531.2 | 28.1 | 472.5 | 579.0 | 6.3 | 6.5 | 1.2% | 17.9 |
| I_5_6_Pachy | 508.2 | 34.9 | 444.2 | 558.9 | 8.1 | 8.1 | 1.6% | 22.4 |
| IT_5_6_Pachy | 510.3 | 34.6 | 431.5 | 568.4 | 8.3 | 8.3 | 1.6% | 23.1 |
# Table 1f Pachymetry measurements - KCN group
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the Optovue logo. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the word is a circular graphic that transitions from orange to yellow. The logo is simple and modern.
# Epithelial Thickness
| Normal Group (N scans=108) | | | | | | | | |
|----------------------------|------|-----|------|------------------|---------------------|-----------------|------|--------|
| | Mean | SD | Min | Max | Repeatability<br>SD | Reproducibility | | |
| | | | | | | SD | COV | Limit* |
| | | | | Zonal Parameters | | | | |
| C_2_Epi | 52.9 | 3.4 | 47.5 | 61.2 | 0.9 | 0.9 | 1.8% | 2.6 |
| T_2_5_Epi | 52.2 | 3.3 | 45.9 | 61.2 | 1.2 | 1.2 | 2.3% | 3.4 |
| ST_2_5_Epi | 51.7 | 2.8 | 47.1 | 59.8 | 1.3 | 1.3 | 2.5% | 3.5 |
| S_2_5_Epi | 52.0 | 2.8 | 47.3 | 59.9 | 1.2 | 1.2 | 2.4% | 3.4 |
| SN_2_5_Epi | 52.9 | 3.1 | 47.6 | 61.5 | 1.2 | 1.2 | 2.2% | 3.3 |
| N_2_5_Epi | 53.4 | 3.0 | 47.3 | 60.7 | 1.1 | 1.1 | 2.0% | 3.0 |
| IN_2_5_Epi | 53.7 | 3.6 | 47.8 | 61.2 | 0.9 | 0.9 | 1.6% | 2.4 |
| I_2_5_Epi | 54.0 | 3.9 | 47.7 | 65.3 | 1.0 | 1.0 | 1.8% | 2.8 |
| IT_2_5_Epi | 53.2 | 3.9 | 46.4 | 63.4 | 1.1 | 1.1 | 2.1% | 3.1 |
| T_5_6_Epi | 52.2 | 3.2 | 45.2 | 59.8 | 1.3 | 1.3 | 2.5% | 3.6 |
| ST_5_6_Epi | 50.8 | 2.6 | 44.8 | 60.1 | 1.4 | 1.5 | 2.9% | 4.0 |
| S_5_6_Epi | 50.9 | 3.0 | 43.7 | 60.7 | 1.3 | 1.4 | 2.7% | 3.8 |
| SN_5_6_Epi | 53.0 | 3.4 | 46.9 | 62.9 | 1.2 | 1.2 | 2.3% | 3.4 |
| N_5_6_Epi | 53.6 | 2.8 | 48.1 | 60.8 | 1.1 | 1.1 | 2.0% | 3.0 |
| IN_5_6_Epi | 53.8 | 3.3 | 48.1 | 59.8 | 1.0 | 1.0 | 1.8% | 2.7 |
| I_5_6_Epi | 54.1 | 3.8 | 47.9 | 66.0 | 1.3 | 1.3 | 2.3% | 3.5 |
| IT_5_6_Epi | 53.4 | 3.6 | 46.7 | 62.4 | 1.3 | 1.3 | 2.4% | 3.6 |
Table 2a. Epithelial thickness measurements - Normal group.
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image contains the logo for Optovue. The logo consists of a circular graphic on the left, with the word "OPTOVUE" in capital letters to the right of the circle. The circle has a gradient of orange and yellow. The text is in a light gray color.
| Corneal Patients Group (Pooled) (N scans=419) | | | | | Repeatability | Reproducibility | | | |
|-----------------------------------------------|------|-----|------|------|---------------|-----------------|------|--------|--|
| | Mean | SD | Min | Max | SD | SD | COV | Limit* | |
| Zonal Parameters | | | | | | | | | |
| C_2_Epi | 51.3 | 4.6 | 38.2 | 64.1 | 1.2 | 1.2 | 2.4% | 3.4 | |
| T_2_5_Epi | 51.3 | 4.7 | 39.7 | 65.2 | 1.4 | 1.4 | 2.7% | 3.9 | |
| ST_2_5_Epi | 51.7 | 4.4 | 40.6 | 63.1 | 1.3 | 1.4 | 2.7% | 3.8 | |
| S_2_5_Epi | 51.8 | 4.6 | 39.1 | 63.7 | 1.4 | 1.4 | 2.7% | 3.8 | |
| SN_2_5_Epi | 52.5 | 4.5 | 41.8 | 63.5 | 1.5 | 1.5 | 2.8% | 4.1 | |
| N_2_5_Epi | 53.1 | 4.2 | 43.1 | 69.1 | 1.4 | 1.4 | 2.6% | 3.9 | |
| IN_2_5_Epi | 52.9 | 4.1 | 41.8 | 65.6 | 1.4 | 1.4 | 2.6% | 3.8 | |
| I_2_5_Epi | 52.2 | 4.9 | 38.0 | 64.9 | 1.4 | 1.4 | 2.7% | 3.9 | |
| IT_2_5_Epi | 51.4 | 5.4 | 37.2 | 65.8 | 1.4 | 1.4 | 2.7% | 3.9 | |
| T_5_6_Epi | 51.7 | 4.5 | 40.6 | 65.2 | 1.6 | 1.7 | 3.2% | 4.6 | |
| ST_5_6_Epi | 51.5 | 4.7 | 37.9 | 64.5 | 1.7 | 1.7 | 3.4% | 4.8 | |
| S_5_6_Epi | 51.1 | 4.8 | 36.5 | 65.1 | 1.7 | 1.7 | 3.4% | 4.8 | |
| SN_5_6_Epi | 52.3 | 4.6 | 41.1 | 66.1 | 1.6 | 1.7 | 3.2% | 4.6 | |
| N_5_6_Epi | 53.4 | 4.6 | 39.2 | 72.8 | 1.6 | 1.7 | 3.1% | 4.7 | |
| IN_5_6_Epi | 53.7 | 4.3 | 41.5 | 65.9 | 1.5 | 1.6 | 2.9% | 4.3 | |
| I_5_6_Epi | 53.0 | 4.4 | 39.1 | 66.7 | 1.9 | 1.9 | 3.6% | 5.3 | |
| IT_5_6_Epi | 52.4 | 4.7 | 40.9 | 72.5 | 1.9 | 1.9 | 3.6% | 5.3 | |
# Table 2b. Epithelial thickness measurements – Corneal Patients pooled group
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image contains the logo for Optovue. The logo consists of a circular graphic on the left, with the word "OPTOVUE" in capital letters to the right of the circle. The circle has a gradient of orange and yellow. The text is in a light gray color.
| Contact Lens Group (N scans=108) | | | | | Repeatability | | Reproducibility | |
|----------------------------------|------|-----|------|------------------|---------------|-----|-----------------|--------|
| | Mean | SD | Min | Max | SD | SD | COV | Limit* |
| | | | | Zonal Parameters | | | | |
| C_2_Epi | 51.0 | 3.6 | 43.2 | 57.8 | 0.8 | 0.9 | 1.8% | 2.6 |
| T_2_5_Epi | 50.6 | 3.4 | 42.3 | 56.9 | 0.9 | 1.1 | 2.1% | 3.0 |
| ST_2_5_Epi | 50.9 | 3.4 | 43.7 | 57.2 | 1.0 | 1.1 | 2.2% | 3.0 |
| S_2_5_Epi | 51.4 | 3.4 | 45.3 | 57.1 | 1.1 | 1.1 | 2.2% | 3.2 |
| SN_2_5_Epi | 52.0 | 3.2 | 46.1 | 57.9 | 1.1 | 1.2 | 2.3% | 3.2 |
| N_2_5_Epi | 51.9 | 2.9 | 45.6 | 57.6 | 0.9 | 1.0 | 2.0% | 2.9 |
| IN_2_5_Epi | 52.0 | 2.9 | 45.4 | 57.0 | 0.8 | 0.8 | 1.6% | 2.3 |
| I_2_5_Epi | 52.1 | 3.2 | 45.2 | 58.4 | 0.8 | 0.9 | 1.7% | 2.5 |
| IT_2_5_Epi | 51.0 | 3.2 | 43.8 | 57.3 | 0.8 | 0.9 | 1.8% | 2.6 |
| T_5_6_Epi | 50.8 | 2.9 | 43.3 | 55.4 | 1.1 | 1.3 | 2.6% | 3.7 |
| ST_5_6_Epi | 51.0 | 3.3 | 44.5 | 57.8 | 1.6 | 1.7 | 3.3% | 4.7 |
| S_5_6_Epi | 51.2 | 3.4 | 44.5 | 57.4 | 1.6 | 1.7 | 3.3% | 4.6 |
| SN_5_6_Epi | 52.5 | 3.4 | 46.0 | 59.3 | 1.3 | 1.4 | 2.7% | 3.9 |
| N_5_6 Epi | 52.5 | 3.2 | 46.8 | 60.3 | 1.1 | 1.3 | 2.4% | 3.5 |
| IN_5_6_Epi | 52.7 | 3.1 | 47.2 | 60.4 | 0.9 | 1.0 | 1.9% | 2.7 |
| I_5_6 Epi | 52.7 | 3.3 | 46.8 | 58.9 | 1.0 | 1.1 | 2.1% | 3.0 |
| IT_5_6 Epi | 51.6 | 3.2 | 44.4 | 57.7 | 0.9 | 1.1 | 2.0% | 2.9 |
# Table 2c. Epithelial thickness measurements – Contact Lens group
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image contains the logo for Optovue. The logo consists of a circular graphic on the left, with the word "OPTOVUE" in capital letters to the right of the circle. The circle has a gradient of orange and yellow. The text is in a light gray color.
| Dry Eye Group (N scans=98) | | | | | | | | | |
|----------------------------|------------------|-----|------|------|---------------------|-----------------|------|--------|--|
| | Mean | SD | Min | Max | Repeatability<br>SD | Reproducibility | | | |
| | | | | | | SD | COV | Limit* | |
| | Zonal Parameters | | | | | | | | |
| C_2_Epi | 51.7 | 3.4 | 43.6 | 60.0 | 1.6 | 1.6 | 3.2% | 4.6 | |
| T_2_5_Epi | 50.5 | 3.3 | 42.7 | 58.6 | 1.9 | 1.9 | 3.9% | 5.4 | |
| ST_2_5_Epi | 49.9 | 4.3 | 40.6 | 59.8 | 1.8 | 1.8 | 3.6% | 5.0 | |
| S_2_5_Epi | 50.0 | 5.5 | 39.1 | 63.7 | 2.0 | 2.0 | 4.1% | 5.7 | |
| SN_2_5_Epi | 51.1 | 5.2 | 41.8 | 63.5 | 2.4 | 2.4 | 4.7% | 6.7 | |
| N_2_5_Epi | 52.1 | 4.7 | 43.7 | 69.1 | 2.1 | 2.2 | 4.3% | 6.1 | |
| IN_2_5_Epi | 52.6 | 4.6 | 41.8 | 65.6 | 2.2 | 2.2 | 4.2% | 6.1 | |
| I_2_5_Epi | 52.7 | 4.4 | 40.9 | 64.9 | 2.4 | 2.4 | 4.5% | 6.5 | |
| IT_2_5_Epi | 52.1 | 4.0 | 42.2 | 65.3 | 2.2 | 2.2 | 4.1% | 6.0 | |
| T_5_6_Epi | 50.2 | 4.2 | 42.9 | 64.6 | 2.0 | 2.1 | 4.1% | 5.8 | |
| ST_5_6_Epi | 49.1 | 5.2 | 37.9 | 60.1 | 1.9 | 2.0 | 4.1% | 5.5 | |
| S_5_6_Epi | 49.3 | 6.9 | 36.5 | 65.1 | 2.0 | 2.1 | 4.2% | 5.8 | |
| SN_5_6_Epi | 50.9 | 6.3 | 41.1 | 66.1 | 2.4 | 2.4 | 4.7% | 6.6 | |
| N_5_6_Epi | 52.8 | 6.4 | 43.7 | 72.8 | 2.5 | 2.5 | 4.8% | 7.0 | |
| IN_5_6_Epi | 52.5 | 5.0 | 41.5 | 65.7 | 2.5 | 2.5 | 4.7% | 6.8 | |
| I_5_6_Epi | 52.4 | 5.1 | 39.1 | 66.7 | 2.9 | 2.9 | 5.5% | 8.0 | |
| IT_5_6_Epi | 52.4 | 5.4 | 41.7 | 72.5 | 2.6 | 2.6 | 4.9% | 7.2 | |
| Table 2d. Epithelial thickness measurements - Dry Eye group | | | |
|-------------------------------------------------------------|--|--|--|
|-------------------------------------------------------------|--|--|--|
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image contains the logo for Optovue. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic that transitions in color from orange at the top to yellow and then green at the bottom. The logo is simple and modern in design.
| Post Laser Refractive Surgery Group (N scans=107) | | | | | | | | | |
|---------------------------------------------------|------|-----|------|------|---------------|-----------------|------|--------|--|
| | Mean | SD | Min | Max | Repeatability | Reproducibility | | | |
| | | | | | SD | SD | COV | Limit* | |
| Zonal Parameters | | | | | | | | | |
| C_2_Epi | 54.0 | 4.6 | 42.8 | 64.1 | 0.6 | 0.7 | 1.2% | 1.9 | |
| T_2_5_Epi | 54.1 | 4.7 | 43.6 | 65.2 | 1.0 | 1.1 | 2.0% | 3.0 | |
| ST_2_5_Epi | 53.2 | 4.4 | 45.2 | 63.1 | 0.9 | 1.0 | 1.8% | 2.7 | |
| S_2_5_Epi | 52.9 | 4.5 | 44.1 | 62.2 | 0.8 | 0.8 | 1.5% | 2.2 | |
| SN_2_5_Epi | 53.4 | 4.1 | 45.6 | 61.4 | 0.7 | 0.7 | 1.4% | 2.1 | |
| N_2_5_Epi | 54.4 | 3.8 | 47.0 | 62.2 | 0.7 | 0.8 | 1.5% | 2.3 | |
| IN_2_5_Epi | 55.2 | 3.7 | 48.1 | 62.8 | 0.8 | 0.8 | 1.5% | 2.4 | |
| I_2_5_Epi | 56.1 | 3.7 | 47.3 | 63.3 | 0.8 | 0.9 | 1.5% | 2.4 | |
| IT_2_5_Epi | 55.5 | 4.8 | 44.5 | 65.8 | 0.9 | 1.0 | 1.7% | 2.7 | |
| T_5_6_Epi | 52.4 | 4.2 | 41.4 | 62.1 | 1.4 | 1.5 | 3.0% | 4.3 | |
| ST_5_6_Epi | 51.4 | 3.6 | 42.4 | 59.2 | 1.4 | 1.6 | 3.1% | 4.3 | |
| S_5_6_Epi | 51.5 | 3.7 | 42.7 | 58.0 | 1.1 | 1.2 | 2.3% | 3.3 | |
| SN_5_6_Epi | 53.0 | 3.8 | 43.5 | 58.3 | 1.0 | 1.1 | 2.0% | 3.0 | |
| N_5_6_Epi | 54.0 | 3.2 | 46.1 | 59.9 | 1.1 | 1.1 | 2.1% | 3.1 | |
| IN_5_6_Epi | 54.7 | 3.8 | 46.6 | 62.4 | 1.1 | 1.2 | 2.2% | 3.3 | |
| I_5_6_Epi | 54.9 | 3.9 | 45.2 | 63.2 | 1.4 | 1.6 | 2.9% | 4.4 | |
| IT_5_6_Epi | 54.6 | 4.2 | 40.9 | 65.5 | 1.4 | 1.6 | 2.9% | 4.4 | |
# Table 2e. Epithelial thickness measurements – Post-LRS group
{21}------------------------------------------------
Image /page/21/Picture/0 description: The image contains the logo for Optovue. The logo consists of a circular graphic on the left, with the word "OPTOVUE" in capital letters to the right of the circle. The circle has a gradient of orange and yellow. The text is in a light gray color.
| Keratoconus Group (N scans=106) | | | | | Repeatability | | Reproducibility | | |
|---------------------------------|------|-----|------|------|---------------|-----|-----------------|--------|--|
| | Mean | SD | Min | Max | SD | SD | COV | Limit* | |
| Zonal Parameters | | | | | | | | | |
| C_2_Epi | 48.6 | 4.8 | 38.2 | 58.4 | 1.4 | 1.5 | 3.0% | 4.1 | |
| T_2_5_Epi | 49.8 | 5.6 | 39.7 | 61.1 | 1.3 | 1.4 | 2.7% | 3.8 | |
| ST_2_5_Epi | 52.6 | 4.4 | 44.3 | 61.7 | 1.5 | 1.5 | 2.9% | 4.3 | |
| S_2_5_Epi | 52.7 | 4.5 | 45.1 | 61.8 | 1.3 | 1.3 | 2.4% | 3.6 | |
| SN_2_5_Epi | 53.3 | 5.0 | 44.2 | 62.2 | 1.2 | 1.2 | 2.3% | 3.5 | |
| N_2_5_Epi | 53.9 | 4.9 | 43.1 | 61.7 | 1.2 | 1.3 | 2.3% | 3.5 | |
| IN_2_5_Epi | 51.8 | 4.2 | 43.9 | 63.2 | 1.3 | 1.3 | 2.5% | 3.6 | |
| I_2_5_Epi | 48.1 | 4.6 | 38.0 | 55.8 | 1.1 | 1.2 | 2.4% | 3.2 | |
| IT_2_5_Epi | 47.0 | 5.5 | 37.2 | 58.4 | 1.2 | 1.3 | 2.7% | 3.5 | |
| T_5_6 Epi | 53.4 | 5.7 | 40.6 | 65.2 | 1.7 | 1.7 | 3.2% | 4.7 | |
| ST_5_6_Epi | 54.3 | 4.9 | 43.7 | 64.5 | 1.6 | 1.7 | 3.1% | 4.7 | |
| S_5_6_Epi | 52.1 | 4.4 | 42.1 | 60.8 | 1.8 | 1.9 | 3.6% | 5.2 | |
| SN_5_6 Epi | 52.7 | 4.5 | 41.2 | 63.8 | 1.5 | 1.6 | 3.1% | 4.5 | |
| N_5_6 Epi | 54.4 | 4.7 | 39.2 | 62.7 | 1.4 | 1.6 | 3.0% | 4.4 | |
| IN_5_6_Epi | 54.7 | 4.7 | 46.2 | 65.9 | 1.1 | 1.2 | 2.2% | 3.4 | |
| I_5_6_Epi | 51.8 | 4.6 | 42.5 | 61.2 | 1.7 | 1.7 | 3.2% | 4.6 | |
| IT_5_6 Epi | 51.1 | 5.1 | 42.7 | 62.4 | 2.1 | 2.1 | 4.1% | 5.8 | |
| | | | Table 2f. Epithelial thickness measurements - KCN group | | ) |
|--|--|--|---------------------------------------------------------|--|---|
|--|--|--|---------------------------------------------------------|--|---|
{22}------------------------------------------------
Image /page/22/Picture/0 description: The image contains the logo for Optovue. The logo consists of a circular graphic on the left side, which transitions in color from orange to yellow. To the right of the graphic is the word "OPTOVUE" in a sans-serif font. The text is in a light gray color.
# Stromal Thickness
| Normal Group (N scans=108) | | | | | | | | |
|----------------------------|-------|------|-------|------------------|---------------------|-----------------|------|--------|
| | Mean | SD | Min | Max | Repeatability<br>SD | Reproducibility | | |
| | | | | Zonal Parameters | | SD | COV | Limit* |
| C_2_Stroma | 485.2 | 20.0 | 449.8 | 539.5 | 1.6 | 2.0 | 0.4% | 5.4 |
| T_2_5_Stroma | 494.1 | 23.1 | 450.8 | 555.7 | 2.4 | 2.6 | 0.5% | 7.1 |
| ST_2_5_Stroma | 512.4 | 23.6 | 475.9 | 579.1 | 3.4 | 3.7 | 0.7% | 10.3 |
| S_2_5_Stroma | 525.3 | 22.9 | 490.9 | 594.1 | 4.2 | 4.6 | 0.9% | 12.7 |
| SN_2_5_Stroma | 523.2 | 21.9 | 491.2 | 593.8 | 4.9 | 4.9 | 0.9% | 13.7 |
| N_2_5_Stroma | 509.6 | 21.8 | 476.7 | 578.9 | 3.6 | 3.6 | 0.7% | 10.0 |
| IN_2_5_Stroma | 497.9 | 20.5 | 463.8 | 556.7 | 2.1 | 2.5 | 0.5% | 7.0 |
| I_2_5_Stroma | 490.1 | 20.1 | 450.4 | 542.5 | 1.9 | 2.5 | 0.5% | 6.9 |
| IT_2_5_Stroma | 487.2 | 21.7 | 444.3 | 540.9 | 1.9 | 2.1 | 0.4% | 5.8 |
| T_5_6_Stroma | 512.9 | 25.4 | 461.2 | 581.9 | 3.6 | 3.7 | 0.7% | 10.2 |
| ST_5_6_Stroma | 542.6 | 25.0 | 503.9 | 618.6 | 5.4 | 5.7 | 1.0% | 15.7 |
| S_5_6_Stroma | 563.0 | 24.1 | 524.2 | 634.2 | 6.2 | 6.7 | 1.2% | 18.5 |
| SN_5_6_Stroma | 556.0 | 24.2 | 519.8 | 634.5 | 7.6 | 7.6 | 1.4% | 21.1 |
| N_5_6_Stroma | 535.7 | 24.5 | 498.2 | 614.0 | 5.1 | 5.1 | 0.9% | 14.1 |
| IN_5_6_Stroma | 519.6 | 23.0 | 482.6 | 583.7 | 3.4 | 3.5 | 0.7% | 9.7 |
| I_5_6_Stroma | 510.5 | 22.4 | 468.4 | 570.4 | 3.2 | 3.3 | 0.7% | 9.3 |
| IT_5_6_Stroma | 503.7 | 24.3 | 451.0 | 567.0 | 3.6 | 3.6 | 0.7% | 10.1 |
### Table 3a. Stromal thickness measurements - Normal group
{23}------------------------------------------------
Image /page/23/Picture/0 description: The image contains the logo for Optovue. The logo consists of the word "OPTOVUE" in a sans-serif font, with the letters in a light gray color. To the left of the word is a circular graphic that fades from orange to yellow. The logo is simple and modern in design.
| Corneal Patients Group (Pooled) (N scans=419) | | | | | Repeatability | | Reproducibility | | |
|-----------------------------------------------|-------|------|-------|------------------|---------------|-----|-----------------|--------|--|
| | Mean | SD | Min | Max | SD | SD | COV | Limit* | |
| | | | | Zonal Parameters | | | | | |
| C_2_Stroma | 456.2 | 49.7 | 351.2 | 630.5 | 2.8 | 3.1 | 0.7% | 8.5 | |
| T_2_5_Stroma | 470.0 | 46.8 | 375.9 | 646.2 | 3.5 | 3.6 | 0.8% | 9.9 | |
| ST_2_5_Stroma | 489.5 | 48.2 | 387.3 | 671.9 | 4.7 | 4.8 | 1.0% | 13.3 | |
| S_2_5_Stroma | 502.5 | 49.2 | 392.3 | 682.1 | 5.3 | 5.4 | 1.1% | 14.9 | |
| SN_2_5_Stroma | 498.8 | 48.0 | 391.2 | 677.4 | 5.6 | 5.6 | 1.1% | 15.6 | |
| N_2_5_Stroma | 484.9 | 46.7 | 383.3 | 656.9 | 4.7 | 4.8 | 1.0% | 13.4 | |
| IN_2_5_Stroma | 471.8 | 47.3 | 372.6 | 637.9 | 3.8 | 4.1 | 0.9% | 11.3 | |
| I_2_5_Stroma | 461.0 | 50.2 | 361.5 | 628.1 | 3.0 | 3.3 | 0.7% | 9.1 | |
| IT_2_5_Stroma | 458.9 | 49.5 | 349.1 | 627.4 | 3.2 | 3.3 | 0.7% | 9.1 | |
| T_5_6_Stroma | 493.4 | 45.2 | 389.7 | 672.0 | 4.8 | 5.0 | 1.0% | 13.9 | |
| ST_5_6_Stroma | 523.6 | 48.5 | 407.4 | 703.4 | 6.8 | 7.0 | 1.3% | 19.3 | |
| S_5_6_Stroma | 544.5 | 50.9 | 425.5 | 715.1 | 8.8 | 9.0 | 1.7% | 25.0 | |
| SN_5_6_Stroma | 535.3 | 48.4 | 425.4 | 714.4 | 8.6 | 8.9 | 1.7% | 24.6 | |
| N_5_6_Stroma | 514.8 | 45.0 | 415.0 | 686.6 | 6.4 | 6.4 | 1.2% | 17.8 | |
| IN_5_6_Stroma | 499.6 | 44.5 | 400.3 | 662.5 | 5.2 | 5.3 | 1.1% | 14.8 | |
| I_5_6_Stroma | 487.5 | 47.9 | 397.3 | 653.5 | 5.4 | 5.5 | 1.1% | 15.3 | |
| IT_5_6_Stroma | 480.8 | 47.5 | 355.8 | 649.5 | 5.2 | 5.3 | 1.1% | 14.7 | |
| Table 3b. Stromal thickness measurements - Corneal Patients pooled group | | | |
|--------------------------------------------------------------------------|--|--|--|
|--------------------------------------------------------------------------|--|--|--|
{24}------------------------------------------------
Image /page/24/Picture/0 description: The image features the logo for Optovue. The logo consists of the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic that transitions in color from yellow to orange. The overall design is clean and modern.
| Contact Lens Group (N scans=108) | | | | | Repeatability | Reproducibility | | | |
|----------------------------------|-------|------|-------|-------|---------------|-----------------|------|--------|--|
| | Mean | SD | Min | Max | SD | SD | COV | Limit* | |
| Zonal Parameters | | | | | | | | | |
| C_2_Stroma | 462.5 | 38.8 | 373.9 | 532.5 | 1.4 | 1.8 | 0.4% | 4.9 | |
| T_2_5_Stroma | 472.1 | 39.6 | 378.6 | 542.3 | 2.2 | 2.4 | 0.5% | 6.6 | |
| ST_2_5_Stroma | 489.2 | 41.8 | 391.1 | 573.8 | 3.5 | 3.6 | 0.7% | 9.9 | |
| S_2_5_Stroma | 502.1 | 43.3 | 400.6 | 594.0 | 4.4 | 4.4 | 0.9% | 12.3 | |
| SN_2_5_Stroma | 499.5 | 42.2 | 399.9 | 586.7 | 4.3 | 4.4 | 0.9% | 12.2 | |
| N_2_5_Stroma | 486.4 | 40.2 | 394.2 | 565.8 | 3.5 | 3.5 | 0.7% | 9.7 | |
| IN_2_5_Stroma | 475.3 | 38.6 | 389.9 | 541.1 | 2.3 | 2.6 | 0.5% | 7.1 | |
| I_2_5_Stroma | 468.0 | 38.4 | 382.4 | 531.7 | 1.9 | 2.6 | 0.6% | 7.3 | |
| IT_2_5_Stroma | 465.8 | 38.5 | 376.6 | 530.5 | 1.8 | 2.5 | 0.5% | 7.0 | |
| T_5_6_Stroma | 490.6 | 41.3 | 389.7 | 563.9 | 3.3 | 3.4 | 0.7% | 9.3 | |
| ST_5_6_Stroma | 518.4 | 45.2 | 407.4 | 610.2 | 5.3 | 5.3 | 1.0% | 14.8 | |
| S_5_6_Stroma | 540.6 | 47.7 | 427.3 | 645.4 | 7.1 | 7.4 | 1.4% | 20.5 | |
| SN_5_6_Stroma | 533.4 | 45.3 | 425.4 | 633.3 | 7.4 | 7.9 | 1.5% | 21.8 | |
| N_5_6_Stroma | 512.8 | 41.9 | 415.0 | 598.5 | 4.8 | 5.1 | 1.0% | 14.1 | |
| IN_5_6_Stroma | 497.5 | 39.3 | 409.1 | 565.4 | 3.5 | 3.6 | 0.7% | 10.0 | |
| I_5_6_Stroma | 489.1 | 39.9 | 397.5 | 558.7 | 3.4 | 3.8 | 0.8% | 10.6 | |
| IT_5_6_Stroma | 482.5 | 40.2 | 385.9 | 555.4 | 3.3 | 3.8 | 0.8% | 10.4 | |
| | | | Table 3c. Stromal thickness measurements - Contact Lens group | | | |
|--|--|--|---------------------------------------------------------------|--|--|--|
|--|--|--|---------------------------------------------------------------|--|--|--|
{25}------------------------------------------------
Image /page/25/Picture/0 description: The image contains the logo for Optovue. The logo features the word "OPTOVUE" in a light gray sans-serif font. To the left of the text is a circular graphic that transitions from orange to yellow. The logo is simple and clean, with a focus on the company name.
| Dry Eye Group (N scan…
