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Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

Sponsor
SynsLaser Kirurgi AS (Other)
Overall Status
Completed
CT.gov ID
NCT02023619
Collaborator
The Research Council of Norway (Other)
40
Enrollment
1
Location
2
Duration (Months)
19.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Retrospective
    Official Title:
    Comparison of Corneal Epithelial and Stromal Thickness Distributions Between Eyes With Keratoconus and Healthy Eyes With Corneal Astigmatism >2.0 D
    Study Start Date :
    Jul 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2013
    Actual Study Completion Date :
    Sep 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Keratoconus

    Eyes with confirmed keratoconus diagnosis
    Astigmatism >2.0 D

    Healthy eyes with astigmatism >2.0 D

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Cornea stromal thickness distribution [Up to 24 weeks]

      A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 SynsLaser Kirurgi AS Tromsø Troms Norway 9008

    Sponsors and Collaborators

    • SynsLaser Kirurgi AS
    • The Research Council of Norway

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aleksandar Stojanovic, Medical director of SynsLaser Surgery AS, SynsLaser Kirurgi AS
    ClinicalTrials.gov Identifier:
    NCT02023619
    Other Study ID Numbers:
    • REK NORD 2013/758
    • SL 1
    First Posted:
    Dec 30, 2013
    Last Update Posted:
    Apr 4, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Aleksandar Stojanovic, Medical director of SynsLaser Surgery AS, SynsLaser Kirurgi AS
    Keratoconus
    Astigmatism
    Cornea
    SD-OCT
    Additional relevant MeSH terms:
    Keratoconus
    Astigmatism

    Study Results

    No Results Posted as of Apr 4, 2019