Completed

Epithelial and Stromal Thickness Comparison in Keratoconus and Healthy Eyes with Corneal Astigmatism

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected from past medical records and data - Retrospective
Who is being recruted

Astigmatism+2

+ Corneal Diseases

+ Eye Diseases

Over 18 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Crossover

Comparing exposures during disease occurrence and non-occurrence in order to assess the short-term effects of triggers.
Observational
Study Start: July 2013
See protocol details

Summary

Principal SponsorSynsLaser Kirurgi AS
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2013

Actual date on which the first participant was enrolled.

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 TitleComparison of Corneal Epithelial and Stromal Thickness Distributions Between Eyes With Keratoconus and Healthy Eyes With Corneal Astigmatism >2.0 D
NCT02023619
Principal SponsorSynsLaser Kirurgi AS
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Crossover

In this design, participants serve as their own control. Researchers compare a person's exposures just before a health event with exposures at other times, helping identify short-term triggers or risk factors.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstigmatismCorneal DiseasesEye DiseasesKeratoconusRefractive Errors

Criteria

2 inclusion criteria required to participate
Keratoconus group: Confirmed diagnosis of keratoconus

Astigmatism group: Healthy eyes with astigmatism of >2.0 D

2 exclusion criteria prevent from participating
Keratoconus group: Keratoconus > stage 3 on Krumeich scale

Astigmatism group: No signs of keratoconus

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

SynsLaser Kirurgi AS

Tromsø, NorwayOpen SynsLaser Kirurgi AS in Google Maps
CompletedOne Study Center