๐ฌIn plain words
What the trial is, and whether it could suit you
This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
1. Male or female โฅ21 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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