Clinical trial NCT02023619: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Keratoconus
Astigmatism
Keywords: Keratoconus
Astigmatism
Cornea
SD-OCT
Lead sponsor: SynsLaser Kirurgi AS
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2013-12-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 20 eyes with diagnosed keratoconus and 20 healthy eyes with 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.

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

Primary outcomes:
measure: Cornea epithelial thickness distribution
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Cornea stromal thickness distribution
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: SynsLaser Kirurgi AS
state: Troms
Study officials:
affiliation: SynsLaser Kirurgi AS
name: Aleksandar Stojanovic, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 2014.