This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.
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.
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
Parallel
N-acetyl cysteine (NAC) 10% solution
DrugN-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.
N-acetyl cysteine (NAC) 20% solution
DrugN-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.
Visine Dry Eye Relief eye drops
DrugVisine Tears Dry Eye Relief artificial tears ophthalmic solution
Level of H2O2 in the aqueous humor
The primary endpoint is the level of H2O2 in the aqueous humor obtained at time of DMEK surgery.
Assessment of safety of NAC eye drops in patients with FECD by documenting the number and severity of adverse events.
Safety assessment will be ongoing for the entire 28 days that study participants take study drug (prior to surgery) and in all post surgical follow-up visits. Assessment will be based on the number and severity of adverse events, with specific scrutiny for evidence of severe ocular adverse reactions such as ocular chemosis, severe injection, presence or worsening of corneal epithelial staining and/or epithelial defects.
Assessment of tolerability of N-acetyl cysteine drops in patients with FECD by documenting participants' reports of irritation, burning, itchiness or redness in their eyes while taking the study drug
Participants will be asked to fill out a tolerability and medication adherence questionnaire where they will rate the irritation, burning, itchiness and redness they experience after using the medication on a scale of 1 to 100.
Change in patient-reported visual disability after NAC administration
Change in patient-reported visual disability will be obtained using the previously validated questionnaire, V-FUCHS instrument 10 before and after the study drug is administered. Participants will be asked how often they experience specific visual difficulties selecting from the following choices: never, rarely, sometimes, most of the time or all of the time. Participants will also be asked how much difficulty they have performing certain visual tasks. Options for the answers are: No difficulty, a little difficulty, moderate difficulty, a lot of difficulty or extreme difficulty.
Change in central corneal thickness after NAC administration
Change in central corneal thickness as measured by CCT; decrease by \>30 µm before and after NAC drop administration period.
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