Epithelial Thickness Map

Status Recruiting

Clinical Trial Summary

In keratoconic eyes, the corneal epithelium shows a localized thinning over the cone that is surrounded by an annulus of epithelial thickening. It has been postulated that epithelial thickness mapping can be a sensitive tool for the keratoconus diagnosis. In keratoconus screening the 5 mm diameter of the corneal centrum may be sufficient while studies have shown that the cone apex is located in this area.

Aim of this study is to assess agreement and repeatability of epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.

Secondary objective is to evaluate the differences between healthy and keratoconus eyes using epithelial thickness map data.

This is a prospective monocentric study that includes patients divided into two groups: patients with keratoconus and a control group formed out of patients without corneal pathologies. For each patient only one eye will be included and corneal measurements will be performed, focused on the corneal epithelium thickness.

Clinical Trial Description

In total 50 eyes of 50 patients will be included, divided into two groups: study group comprised of 20 eyes with diagnosed keratoconus and a control group formed out of 30 healthy eyes.

Patients included in the study will be measured with the corneal acquisition mode, also allowing for epithelium thickness data, on each device without pupil dilatation. After each measurement patients will be asked to blink in order to allow adequate tear-film recovery. Each patient will be measured three times with both devices. Only one visit will be necessary.

The order in which the measurements will be performed (Anterion or MS-39) will be randomised using randomised.org.

The corneal epithelial thickness will be measured as the distance between the air-tear and the epithelium-Bowman interfaces.

Main outcome variable:

- Mean differences in central corneal epithelial thickness between the devices investigated (+ limits of agreement (1.96xSD) between the investigated devices)

Secondary outcome variables:

- Repeatability coefficient (within subject standard deviation - SD) and coefficient of variation of the two devices

- Comparison in epithelial thickness between normal and keratoconus eyes

- Sensitivity and specificity of swept-source OCT device in keratoconus diagnosis ;

Study Design

Related Conditions & MeSH terms

Keratoconus

Clinical Trial Details

NCT number	NCT04578184
Study type	Interventional
Source	Vienna Institute for Research in Ocular Surgery
Contact	Oliver Findl, Prof., MD
Phone	+43 1 91021-84611
Email	hkh.augen.abt@wgkk.at
Status	Recruiting
Phase	N/A
Start date	October 15, 2020
Completion date	March 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.