Clinical Trials Directory

Trials / Completed

CompletedNCT02023619

Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

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

Status
Completed
Phase
Study type
Observational
Enrollment
40 (actual)
Sponsor
SynsLaser Kirurgi AS · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Timeline

Start date
2013-07-01
Primary completion
2013-09-01
Completion
2013-09-01
First posted
2013-12-30
Last updated
2019-04-04

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT02023619. Inclusion in this directory is not an endorsement.