Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

Completed

• Conditions: Astigmatism; Keratoconus

• Registration Number: NCT02023619
• Lead Sponsor: SynsLaser Kirurgi AS

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.

Study Timeline

• Study Start: 2013-07
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Study First Submitted: 2013-12-12
• Study First Submitted QC: 2013-12-23
• Study First Posted: 2013-12-30
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cornea epithelial thickness distribution	Up to 24 weeks	A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination

Secondary Outcome Measures

Name	Time	Method
Cornea stromal thickness distribution	Up to 24 weeks	A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination

Trial Locations

Locations (1)

SynsLaser Kirurgi AS; 🇳🇴 Tromsø, Troms, Norway