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NCT03184610 Clinical Trial

Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution OCT

Keratoconus Clinical Trial

Official title:
Distinguishing Healthy and Keratoconic Eyes Using Ultrahigh-Resolution Optical Coherence Tomography (UHR-OCT) Based Corneal Epithelium Thickness Mapping

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03184610
Other study ID # 1160/2014
Secondary ID
Status Completed
Phase N/A
First received June 9, 2017
Last updated June 9, 2017
Start date December 2014

Study information
Verified date June 2017
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The OCT used in this trial offers the advantage of both a non-contact method and a very high axial resolution. Determined parameters with the highest potential of diagnostic discrimination between eyes with Keratoconus and healthy eyes are investigated. Aim of this trial is to investigate differences of specific parameters of epithelium thickness maps at healthy eyes and eyes with Keratoconus.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date
Est. primary completion date June 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria:

- Age>18

- Existence of Keratoconus

- written informed consent obtained

Exclusion Criteria:

- Earlier surgery such as PK, CXL, relaxing incisions

- Systemic diseases

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• OCT-scanning
All participants will be scanned with a OCT-device

Locations
Country Name City State
Austria Medical University of Vienna, Department of Ophthalmology Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Corneal Epithelium Thickness Parameters collected from epithelium thickness data and maps One visit
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