RecruitingPhase 2NCT04440280

Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy


Sponsor

Massachusetts Eye and Ear Infirmary

Enrollment

45 participants

Start Date

Sep 16, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called N-Acetylcysteine (NAC) eye drops — typically used as a mucolytic (a drug that thins mucus) in respiratory conditions — can help patients with Fuchs' Endothelial Corneal Dystrophy (FECD). FECD is a genetic eye disease where the cells lining the back of the cornea gradually die off, causing the cornea to become cloudy, leading to blurred vision and glare. Researchers believe that oxidative stress (damage from reactive oxygen species) plays a major role in this cell death, and NAC is a powerful antioxidant that might slow this damage. Participants are patients who need DMEK surgery (a type of corneal transplant) combined with cataract surgery. They will receive NAC eye drops either before or after surgery and be followed to see if outcomes like corneal clarity and cell survival improve compared to standard care. You may be eligible if: - You are 21 or older - You have advanced FECD and a visually significant cataract - You are scheduled for DMEK surgery combined with cataract surgery You may NOT be eligible if: - You are pregnant, breastfeeding, or unwilling to use birth control during the study - You have had prior eye surgery in the study eye (including cataract, glaucoma, or retinal surgery) - You have other corneal diseases (severe dry eye, corneal scars, infections) - You have used N-Acetylcysteine systemically or topically within the past 30 days - You have a known intolerance to topical N-Acetylcysteine Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGN-acetyl cysteine (NAC) 10% solution

N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.

DRUGN-acetyl cysteine (NAC) 20% solution

N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.

DRUGVisine Dry Eye Relief eye drops

Visine Tears Dry Eye Relief artificial tears ophthalmic solution


Locations(1)

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04440280


Related Trials