Clinical trial NCT04175938: Assessment of Corneal Endothelial Function Following Hypoxic Stress
Official title: Assessment of Corneal Endothelial Function Following Hypoxic Stress
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Fuchs' Endothelial Corneal Dystrophy
Keywords: Fuch's Dystrophy, FECD, Fuch's Endothelial Corneal Dystrophy
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2019-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

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Primary outcomes:
measure: Thickness of the cornea before and after the stress test
timeFrame: seven hours
measure: The rate of corneal recovery after the stress test
timeFrame: three hours
measure: Time to full recovery from swelling
timeFrame: three hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
References: