Assessment of Corneal Endothelial Function Following Hypoxic Stress

Assessment of Corneal Endothelial Function Following Hypoxic Stress

Sponsors

Lead Sponsor: Massachusetts Eye and Ear Infirmary

Source Massachusetts Eye and Ear Infirmary
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.

Overall Status Recruiting
Start Date 2020-07-01
Completion Date 2021-11-30
Primary Completion Date 2021-11-30
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Thickness of the cornea before and after the stress test seven hours
The rate of corneal recovery after the stress test three hours
Time to full recovery from swelling three hours
Enrollment 20
Condition
Intervention

Intervention Type: Device

Intervention Name: Wearing of contact lens

Description: 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.

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 -

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Stacey M Ellender, PhD

Phone: 617-573-5507

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Massachusetts Eye and Ear Infirmary Stacey Ellender, PhD 617-573-6060 [email protected] Ula Jurkunas, MD Principal Investigator Jia Yin, MD, PhD Sub-Investigator
Location Countries

United States

Verification Date

2020-01-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Massachusetts Eye and Ear Infirmary

Investigator Full Name: Ula Jurkunas, MD

Investigator Title: Associate Professor, Harvard Medical School

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Subjects with Fuch's Endothelial Dystrophy

Type: Active Comparator

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

Label: Subjects with healthy eyes

Type: Other

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

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

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

Masking: None (Open Label)

Source: ClinicalTrials.gov

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