Actively Recruiting

Phase 2
Age: 21Years +
All Genders
NCT04440280

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

Led by Massachusetts Eye and Ear Infirmary · Updated on 2025-09-29

45

Participants Needed

1

Research Sites

345 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female 21 years of age or older at time of surgical evaluation
  • Diagnosis of advanced FECD and visually significant cataract
  • Indication for combined Descemet Membrane Endothelial Keratoplasty (DMEK) and cataract surgery
  • Written informed consent obtained and ability to comply with study requirements
  • Willingness and ability to follow the medication regimen
Not Eligible

You will not qualify if you...

  • Pregnant, breastfeeding, or unwilling to use birth control during study participation
  • History of prior intraocular surgery in the study eye, including cataract, glaucoma, or retina surgery
  • History of other corneal diseases such as severe dry eye, corneal scars, pseudophakic bullous keratopathy, corneal degenerations, or infections
  • Use of ocular prescription medications except 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
  • Any condition or abnormality that may compromise patient safety or data quality according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts Eye and Ear Infirmary

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

M

Michael Cheung, MSc, CCRP

CONTACT

U

Ula Jurkunas, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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