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

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.

Conditions

Fuchs Endothelial Corneal Dystrophy

Study Overview

Study Details

Study overview

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

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

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

Condition
Fuchs Endothelial Corneal Dystrophy
Intervention / Treatment

-

Contacts and Locations

Boston

Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, United States, 02114

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts Eye and Ear Infirmary,

Ula Jurkunas, MD, PRINCIPAL_INVESTIGATOR, Mass Eye and Ear

Study Record Dates

2025-04-30