Assessment of Corneal Endothelial Function Following Hypoxic Stress
Primary Purpose
Fuchs' Endothelial Corneal Dystrophy
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Wearing of contact lens
Sponsored by
About this trial
This is an interventional health services research trial for Fuchs' Endothelial Corneal Dystrophy focused on measuring Fuch's Dystrophy, FECD, Fuch's Endothelial Corneal Dystrophy
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
-
Sites / Locations
- Massachusetts Eye and Ear InfirmaryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Subjects with Fuch's Endothelial Dystrophy
Subjects with healthy eyes
Arm Description
Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours.
Persons with healthy eyes will wear a contact lens in one eye for three hours.
Outcomes
Primary Outcome Measures
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
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
Time to full recovery from swelling
The time it takes for the eye to no longer be swollen
Secondary Outcome Measures
Full Information
NCT ID
NCT04175938
First Posted
November 18, 2019
Last Updated
January 25, 2023
Sponsor
Massachusetts Eye and Ear Infirmary
1. Study Identification
Unique Protocol Identification Number
NCT04175938
Brief Title
Assessment of Corneal Endothelial Function Following Hypoxic Stress
Official Title
Assessment of Corneal Endothelial Function Following Hypoxic Stress
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
November 30, 2025 (Anticipated)
Study Completion Date
November 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Endothelial Corneal Dystrophy
Keywords
Fuch's Dystrophy, FECD, Fuch's Endothelial Corneal Dystrophy
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Subjects with Fuch's Endothelial Dystrophy
Arm Type
Active Comparator
Arm Description
Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours.
Arm Title
Subjects with healthy eyes
Arm Type
Other
Arm Description
Persons with healthy eyes will wear a contact lens in one eye for three hours.
Intervention Type
Device
Intervention Name(s)
Wearing of contact lens
Intervention 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.
Primary Outcome Measure Information:
Title
Thickness of the cornea before and after the stress test
Description
Maximum changes in the thickness of the cornea measured before and after the stress test
Time Frame
seven hours
Title
The rate of corneal recovery after the stress test
Description
The extent of swelling evident at regular intervals during the 3 hours after the stress test
Time Frame
three hours
Title
Time to full recovery from swelling
Description
The time it takes for the eye to no longer be swollen
Time Frame
three hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey M Ellender, PhD
Phone
617-573-5507
Email
stacey_ellender@meei.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Quinkert, PhD
Phone
617-573-6060
Email
amy_Quinkert@meei.harvard.edu
Facility Information:
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Ellender, PhD
Phone
617-573-6060
Email
stacey_ellender@meei.harvard.edu
First Name & Middle Initial & Last Name & Degree
Lynette Johns, OD
Email
lynette_johns@meei.harvard.edu
First Name & Middle Initial & Last Name & Degree
Ula Jurkunas, MD
First Name & Middle Initial & Last Name & Degree
Jia Yin, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
Assessment of Corneal Endothelial Function Following Hypoxic Stress
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