Comparison of Corneal Epithelial and Stromal Thickness Distributions Between Eyes With Keratoconus and Healthy Eyes With Corneal Astigmatism >2.0 D
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Keratoconus
- Sponsor
- SynsLaser Kirurgi AS
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cornea epithelial thickness distribution
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Aleksandar Stojanovic
Medical director of SynsLaser Surgery AS
SynsLaser Kirurgi AS
Eligibility Criteria
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
Outcomes
Primary Outcomes
Cornea epithelial thickness distribution
Time Frame: Up to 24 weeks
A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination
Secondary Outcomes
- Cornea stromal thickness distribution(Up to 24 weeks)