Corneal Epithelial and Stromal Thickness Distribution in Keratoconus

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02023619

Enrollment

Registered

2013-12-30

Start date

2013-07-31

Completion date

2013-09-30

Last updated

2019-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Astigmatism, Keratoconus

Keywords

Keratoconus, Astigmatism, Cornea, SD-OCT

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.

Interventions

None listed

Study design

Observational model

CASE_CROSSOVER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Cornea epithelial thickness distribution	Up to 24 weeks	A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination

Secondary

Measure	Time frame	Description
Cornea stromal thickness distribution	Up to 24 weeks	A single non-invasive measurement by OCT evaluated up to 24 weeks after the examination

Countries

Norway

Outcome results