NCT04440280 · Massachusetts Eye and Ear Infirmary
Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy
What this study is about
This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.
View original scientific description
This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female ≥21 years of age at time of surgical evaluation.
- Diagnosis of advanced FECD and visually significant cataract
- Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent cataract surgery
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
- Willingness and ability to adhere to medication regimen
Exclusion criteria
- Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
- History of prior intraocular surgery in study eye including cataract, glaucoma and/or retina surgery
- History of other corneal diseases, such as severe dry eye, corneal scars, pseudophakic bullous keratopathy, corneal degenerations, corneal infections
- Use of ocular prescription medications except for lubricants, hyperosmotic agents, or ocular hypotensive agents
- History of ocular surface infection within the past 30 days
- Use of systemic, inhalational, or topical N-Acetylcysteine within the past 30 days
- History of intolerance to topical N-Acetylcysteine
- 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. \-
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2025 · Source of record for eligibility and locations