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NCT02023619 Clinical Trial

Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

Astigmatism Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02023619
Other study ID # REK NORD 2013/758
Secondary ID SL 1
Status Completed
Phase
First received
Last updated
Start date July 2013
Est. completion date September 2013

Study information
Verified date April 2019
Source SynsLaser Kirurgi AS
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Norway SynsLaser Kirurgi AS Tromsø Troms

Sponsors (2)
Lead Sponsor Collaborator
SynsLaser Kirurgi AS The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Zhou W, Stojanovic A. Comparison of corneal epithelial and stromal thickness distributions between eyes with keratoconus and healthy eyes with corneal astigmatism = 2.0 D. PLoS One. 2014 Jan 28;9(1):e85994. doi: 10.1371/journal.pone.0085994. eCollection 2 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cornea epithelial thickness distribution A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination Up to 24 weeks
Secondary Cornea stromal thickness distribution A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination Up to 24 weeks
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