Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

April 2, 2019 updated by: Aleksandar Stojanovic, SynsLaser Kirurgi AS

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Troms
      • Tromsø, Troms, Norway, 9008
        • SynsLaser Kirurgi AS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

20 eyes with diagnosed keratoconus and 20 healthy eyes with astigmatism >2.0 D

Description

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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Keratoconus
Eyes with confirmed keratoconus diagnosis
Astigmatism >2.0 D
Healthy eyes with astigmatism >2.0 D

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SynsLaser Kirurgi AS

Collaborators

The Research Council of Norway

Investigators

  • Principal Investigator: Aleksandar Stojanovic, MD, SynsLaser Kirurgi AS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

September 1, 2013

Study Completion (ACTUAL)

September 1, 2013

Study Registration Dates

First Submitted

December 12, 2013

First Submitted That Met QC Criteria

December 23, 2013

First Posted (ESTIMATE)

December 30, 2013

Study Record Updates

Last Update Posted (ACTUAL)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK NORD 2013/758
  • SL 1 (OTHER: SynsLaser)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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