Testing Eye Drops with N-acetyl Cysteine to Treat Advanced Fuchs Endothelial Corneal Dystrophy with Cataracts Randomized, Double-Blind Trial Comparing Two Concentrations of NAC to Placebo Before Eye Surgery

What this Trial Is About

Fuchs Endothelial Corneal Dystrophy FECD is a common corneal disorder affecting about 4% of people over 40 in the US. This research evaluates whether applying N-acetyl cysteine NAC eye drops can reduce oxidative stress and protect cells in patients with FECD. There are currently no medical treatments to halt FECD progression, and corneal transplantation is the main option. This trial aims to find a drug therapy to prevent cell loss in early to late FECD stages and support graft survival after surgery. This is a single-center, double-blind, placebo-controlled, randomized study involving adult participants with advanced FECD and cataracts who need combined Descemet Membrane Endothelial Keratoplasty DMEK and cataract surgery. Participants will be assigned to receive either 10% NAC eye drops, 20% NAC eye drops, or placebo artificial tears. They will self-administer one drop four times daily in the eye planned for surgery over 28 days before the operation. If no significant difference is found after the initial 30 eyes, an additional 15 eyes will be enrolled for 20% NAC treatment. Participants will complete visual disability questionnaires and tolerability and adherence surveys before and after using the study medication. Corneal measurements and images will be taken. During surgery, aqueous humor fluid and corneal tissue normally discarded will be collected for research. Researchers will measure levels of hydrogen peroxide in the eye fluid, monitor safety and side effects, and assess changes in corneal thickness, cell counts, tomography, and patient-reported vision. The study includes ongoing safety monitoring through surgery and post-operative follow-up over about 6 to 7 weeks.

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