Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

Study Overview
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Brief Summary
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The purpose of the study was to identify corneal epithelial- and stromal-thickness distribution patterns in keratoconic eyes using spectral-domain-optical coherence tomography (SD-OCT). Study Hypothesis: SD-OCT provides necessary details about the distribution of corneal epithelial and stromal thicknesses for identification of a pattern characteristic for early keratoconus.

Detailed Description
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Purpose of the study: To characterize epithelial and stromal thickness distribution in keratoconic eyes and to develop epithelial and stromal thickness-based variables for keratoconus detection. Methodology: SD-OCT corneal scans of 20 eyes with keratoconus (group 1) and 20 healthy eyes with > 2 diopters (D) of corneal astigmatism as controls (group 2) are studied. Keratoconus patients referred to the Eye Dpt. of the University Hospital North Norway for CXL (Corneal collagen cross-linking)- treatment and healthy subjects seeking preoperative evaluation for refractive surgery at SynsLaser® Kirurgi AS Tromsø clinic are examined by corneal SD-OCT as a part of their routine examination. Analysis of their SD-OCT corneal scans is used for the purpose of this study.Two cross-sectional meridional corneal profiles (along steepest and flattest meridians, located by a Scheimpflug-based corneal topography) for each individual are obtained by using a RTVue100® (Optovue Inc. Fremont, California, USA), 26000-Hz SD-OCT across the central 6mm diameter of the cornea.

Official Title
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Comparison of Corneal Epithelial and Stromal Thickness Distributions Between Eyes With Keratoconus and Healthy Eyes With Corneal Astigmatism >2.0 D

Conditions
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Keratoconus, Astigmatism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Keratoconus group: Confirmed diagnosis of keratoconus Astigmatism group: Healthy eyes with astigmatism of >2.0 D Exclusion Criteria: Keratoconus group: Keratoconus > stage 3 on Krumeich scale Astigmatism group: No signs of keratoconus

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Keratoconus<br>Eyes with confirmed keratoconus diagnosis | |
| Astigmatism >2.0 D<br>Healthy eyes with astigmatism >2.0 D | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cornea epithelial thickness distribution | A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cornea stromal thickness distribution | A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination | Up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cornea, Keratoconus, Astigmatism, SD-OCT