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OpenTrials
Completed

NCT Number: NCT02023619

Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

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.

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Key information

Conditions

Keratoconus Astigmatism Corneal Diseases Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SynsLaser Kirurgi AS

Tromsø, Troms, 9008, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

SynsLaser Kirurgi AS

Other

Collaborators

  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2013
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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