Using N-acetyl cysteine eye drops to treat Fuchs Endothelial Corneal Dystrophy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of topical N-acetyl cysteine (NAC) eye drops in reducing oxidative stress and providing cytoprotection in patients with Fuchs Endothelial Corneal Dystrophy (FECD). The study involves adult participants with advanced FECD and cataracts who are eligible for combined Descemet Membrane Endothelial Keratoplasty (DMEK) and cataract surgery. It is a single center, double-blind, placebo-controlled, randomized trial conducted at Massachusetts Eye and Ear, aiming to identify a pharmacotherapeutic intervention to prevent endothelial cell loss and improve graft survival. The trial compares different concentrations of NAC with a placebo to assess their impact on disease progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female ≥21 years of age at time of surgical evaluation.
2. Diagnosis of advanced FECD and visually significant cataract
3. Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent cataract surgery
4. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
5. Willingness and ability to adhere to medication regimen

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
2. History of prior intraocular surgery in study eye including cataract, glaucoma and/or retina surgery
3. History of other corneal diseases, such as severe dry eye, corneal scars, pseudophakic bullous keratopathy, corneal degenerations, corneal infections
4. Use of ocular prescription medications except for lubricants, hyperosmotic agents, or ocular hypotensive agents
5. History of ocular surface infection within the past 30 days
6. Use of systemic, inhalational, or topical N-Acetylcysteine within the past 30 days
7. History of intolerance to topical N-Acetylcysteine
8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

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Where it's running

• Massachusetts Eye and Ear Infirmary
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Ula Jurkunas, MD — Mass Eye and Ear
• Study coordinator: Michael Cheung, MSc, CCRP
• Email: mcheung0@meei.harvard.edu
• Phone: 6175736060

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Polishing the Descemet membrane before endothelial keratoplasty for Fuchs endothelial corneal dystrophy

  This trial tests whether polishing the diseased Descemet membrane before injecting cultured endothelial cells helps improve graft adhesion and outcomes for people with Fuchs endothelial corneal dystrophy.

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• Lying on your back after DMEK: 1 day versus 5 days

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• VALIDATING the SUCCESS Score to predict need for endothelial keratoplasty after cataract surgery in Fuchs dystrophy

  This study will test whether the SUCCESS Score, with corneal densitometry, can predict which people with Fuchs endothelial corneal dystrophy having cataract surgery will later need endothelial keratoplasty.

  Recruiting Instituto Ramón y Cajal de Investigación Sanitaria · Madrid, Madrid · NCT07265388

• DT-168 for people with Fuchs endothelial corneal dystrophy who are having a corneal transplant

  This study will test whether DT-168 eye drops are safe, well tolerated, and how they act in people with Fuchs endothelial corneal dystrophy who are scheduled for corneal transplant.

  Recruiting at 2 sites Phase 2 Design Therapeutics, Inc. · Indianapolis, Indiana and 1 other locations · NCT07024693

• Comparing femtosecond laser-assisted versus conventional cataract surgery for people with Fuchs endothelial corneal dystrophy

  This study will test whether femtosecond laser-assisted cataract surgery or conventional phacoemulsification better preserves corneal endothelial cells and vision in adults with moderate to severe Fuchs endothelial corneal dystrophy who need cataract surgery.

  Recruiting Eye & ENT Hospital of Fudan University · Shanghai, Shanghai Municipality · NCT06966167

• Observing outcomes of posterior lamellar keratoplasty for eye conditions

  This study looks at how well two types of eye surgeries for conditions like Fuchs' dystrophy and bullous keratopathy work in helping patients see better over time.

  Recruiting Centre Hospitalier Régional Metz-Thionville · Metz · NCT06859411

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.