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Contact Lens Wear for Fuchs' Dystrophy

Phase 1 & 2
Recruiting
Research Sponsored by Massachusetts Eye and Ear Infirmary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a clinical diagnosis of Fuchs endothelial corneal dystrophy
Have no prior history of ocular disease including ocular surface disease or glaucoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three hours
Awards & highlights

Study Summary

This trial will compare corneal thickness in healthy vs unhealthy eyes to see if there is a difference in response to contact lens placement.

Who is the study for?
This trial is for individuals with Fuchs endothelial corneal dystrophy (FECD) who are scheduled for a corneal transplant within the next 6 months. Participants should not have had previous eye surgery, contact lens intolerance, or other ocular diseases like glaucoma.Check my eligibility
What is being tested?
The study aims to measure how much the cornea swells in response to wearing a contact lens as a stress test. It compares this swelling between people with healthy eyes and those with FECD before and after the test.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include discomfort from wearing contact lenses, temporary vision changes due to corneal swelling, and possible irritation or infection risks associated with lens use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with Fuchs' dystrophy.
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I have never had eye diseases like surface issues or glaucoma.
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I have never had eye surgery on my study eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~seven hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and seven hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The rate of corneal recovery after the stress test
Cornea
Time to full recovery from swelling

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Subjects with healthy eyesExperimental Treatment1 Intervention
Persons with healthy eyes will wear a contact lens in one eye for three hours.
Group II: Subjects with Fuch's Endothelial DystrophyActive Control1 Intervention
Persons with a diagnosis of Fuch's Endothelial Dystrophy will wear a contact lens in an affected eye for three hours.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
106 Previous Clinical Trials
12,916 Total Patients Enrolled

Media Library

Subjects with healthy eyes Clinical Trial Eligibility Overview. Trial Name: NCT04175938 — Phase 1 & 2
Fuchs' Dystrophy Research Study Groups: Subjects with Fuch's Endothelial Dystrophy, Subjects with healthy eyes
Fuchs' Dystrophy Clinical Trial 2023: Subjects with healthy eyes Highlights & Side Effects. Trial Name: NCT04175938 — Phase 1 & 2
Subjects with healthy eyes 2023 Treatment Timeline for Medical Study. Trial Name: NCT04175938 — Phase 1 & 2
Fuchs' Dystrophy Patient Testimony for trial: Trial Name: NCT04175938 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there currently any openings for participants in this research?

"According to clinicaltrials.gov, this medical experiment is currently enrolling participants. Initially posted on the 1st of July in 2023 and recently updated on the 25th of January in 2023."

Answered by AI

How many individuals are being granted admittance to this research endeavor?

"Affirmative. Clinicaltrials.gov gathers that this medical trial, posted on July 1st 2023 and recently revisited on January 25th 2023, is presently searching for eligible volunteers. The study requires the recruitment of around twenty individuals from a single centre."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I was searching the internet for help for surgery or alternatives to surgery since we cannot afford it.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Recent research and studies
clinicaltrials.govStudy
Assessment of Corneal Endothelial Function Following Hypoxic Stress
Ula Jurkunas 2023. "Assessment of Corneal Endothelial Function Following Hypoxic Stress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04175938.
~13 spots leftby Nov 2025
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