Assessment of Corneal Endothelial Function Following Hypoxic Stress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-31

Study Completion Date

2027-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluation of Central Corneal Thickness in Patients With Vernal Keratoconjunctivitis Using Topical Steroids

NCT06913790

Vernal Keratoconjunctivitis

ACTIVE_NOT_RECRUITING

One Week Assessment of The Phenacite Lens

NCT02553395

Myopia

COMPLETED NA

Corneal Thickness Changes With Scleral Contact Lenses

NCT03249233

Keratoconus Healthy Controls

UNKNOWN NA

Contact Lenses and Infiltrative Keratitis

NCT02186431

Keratitis

COMPLETED NA

A Clinical Evaluation of Two Contact Lenses Used With Three Care Systems

NCT04195581

Myopia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Fuchs' Endothelial Corneal Dystrophy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects with Fuch's Endothelial Dystrophy

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

Group Type ACTIVE_COMPARATOR

Wearing of contact lens

Intervention Type DEVICE

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.

Subjects with healthy eyes

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

Group Type OTHER

Wearing of contact lens

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wearing of contact lens

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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