Assessment of Corneal Endothelial Function Following Hypoxic Stress

Mass Eye and Ear

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Fuchs' Endothelial Corneal Dystrophy

Treatments: Device: Wearing of contact lens

Study type: Interventional

Funder types: Other

Identifiers

NCT04175938

2019P002073

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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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Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Subjects with Fuch's Endothelial Dystrophy

Active Comparator group

Description:

Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours.

Treatment:

Device: Wearing of contact lens

Subjects with healthy eyes

Other group

Description:

Persons with healthy eyes will wear a contact lens in one eye for three hours.

Treatment:

Device: Wearing of contact lens