Assessment of Corneal Endothelial Function Following Hypoxic Stress

Study Overview
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Brief Summary
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The purpose of this study is to determine the difference in the cornea's response to contact lens placement between healthy and unhealthy eyes. The amount of corneal swelling (corneal thickness) between normal and FECD patients before and after a stress test will be measured and compared.

Detailed Description
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Clarity of the cornea is essential for optimal vision. The endothelium is a layer within the cornea that controls its clarity. Fuchs endothelial corneal dystrophy (FECD) is a progressive disease that affects both eyes in which the endothelium is dysfunctional, causing the cornea to swell and lose its clarity. Because of the vision loss associated with this swelling, corneal transplantation is needed for patients with advanced FECD. Currently, there is no method to directly measure how well endothelium cells are functioning in patients with FECD. Such a measurement, if it were possible, would allow physicians to identify patients who are at a higher risk of corneal swelling. The goal of this study is to establish a tool to measure and compare the amounts of corneal swelling between normal and FECD patients after a stress test is performed (the wearing of an FDA-approved contact lens.) Data will also be collected regarding how quickly and how well a cornea recovers from swelling in patients with healthy eyes compared to those with FECD.

Official Title
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Assessment of Corneal Endothelial Function Following Hypoxic Stress

Conditions
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Fuchs' Endothelial Corneal Dystrophy

Intervention / Treatment
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* Device: Wearing of contact lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects in the Fuch's Dystrophy arm of the study must meet following criteria: Have a clinical diagnosis of Fuchs endothelial corneal dystrophy Be scheduled for corneal transplantation in the next 6 months Have no history of prior ocular surgery in study eye Have no history of contact lens intolerance Be motivated and willing to complete ocular imaging tests Subjects in the healthy eyes arm of the study must meet following criteria: Have no prior history of ocular disease including ocular surface disease or glaucoma Have no history of prior ocular surgery in study eye Have no history of contact lens intolerance Be motivated and willing to complete ocular imaging tests Exclusion Criteria: Pregnant women -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A stress test will be performed (the wearing of a contact lens) to induce swelling in two groups: group A where the subjects have a diagnosis of Fuch's Endothelial Corneal Dystrophy, and group B where subjects have healthy eyes. Once the contact lens is removed, the cornea swelling will be measured in each group. The length of time it takes for the cornea to recover after being swollen will also be compared between the two groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subjects with Fuch's Endothelial Dystrophy<br>Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours. | Device: Wearing of contact lens<br>* All subjects will wear a contact lens for three hours. The effect of the lens on the eye (epithelial swelling) will be measured at intervals after the lens is removed.<br>|
| Other: Subjects with healthy eyes<br>Persons with healthy eyes will wear a contact lens in one eye for three hours. | Device: Wearing of contact lens<br>* All subjects will wear a contact lens for three hours. The effect of the lens on the eye (epithelial swelling) will be measured at intervals after the lens is removed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of the cornea before and after the stress test | Maximum changes in the thickness of the cornea measured before and after the stress test | seven hours | 
| The rate of corneal recovery after the stress test | The extent of swelling evident at regular intervals during the 3 hours after the stress test | three hours | 
| Time to full recovery from swelling | The time it takes for the eye to no longer be swollen | three hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fuch's Dystrophy, FECD, Fuch's Endothelial Corneal Dystrophy