Brief Title
Corneal Epithelial and Stromal Thickness Distribution in Keratoconus
Official Title
Comparison of Corneal Epithelial and Stromal Thickness Distributions Between Eyes With Keratoconus and Healthy Eyes With Corneal Astigmatism >2.0 D
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.
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
Primary Outcome
Cornea epithelial thickness distribution
Secondary Outcome
Cornea stromal thickness distribution
Condition
Keratoconus
Study Arms / Comparison Groups
Keratoconus
Description: Eyes with confirmed keratoconus diagnosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
40
Start Date
July 2013
Completion Date
September 2013
Primary Completion Date
September 2013
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Aleksandar Stojanovic, MD, ,
Location Countries
Norway
Location Countries
Norway
Administrative Informations
NCT ID
NCT02023619
Organization ID
REK NORD 2013/758
Secondary IDs
SL 1
Responsible Party
Principal Investigator
Study Sponsor
SynsLaser Kirurgi AS
Collaborators
The Research Council of Norway
Study Sponsor
Aleksandar Stojanovic, MD, Principal Investigator, SynsLaser Kirurgi AS
Verification Date
April 2019