Assessment of Corneal Endothelial Function Following Hypoxic Stress

NCT04175938 | Withdrawn Phase 1 FDA Device

• 1 other identifier: 2019P002073
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Fuchs' Endothelial Corneal Dystrophy

Keywords

Fuch's Dystrophy, FECD, Fuch's Endothelial Corneal Dystrophy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Subjects with Fuch's Endothelial Dystrophy

ACTIVE COMPARATOR

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

Subjects with healthy eyes

OTHER

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

Device: Wearing of contact lens

Interventions

Wearing of contact lens 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 Fuch's Endothelial Dystrophy; Subjects with healthy eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Massachusetts Eye and Ear Infirmary: lead

Study Sites (1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Fuchs' Endothelial Dystrophy

Condition Hierarchy (Ancestors)

Corneal Dystrophies, Hereditary; Corneal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Ula Jurkunas, MD

  Massachusetts Eye and Ear

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Harvard Medical School

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 25, 2019
• Study Start: December 1, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2027
• Last Updated: March 2, 2026

Record last verified: 2025-09

Locations

US (1)