Comparing Mid- to Long-Term Outcomes of Femtosecond Laser-Assisted and Conventional Cataract Surgery in Patients with Moderate to Severe Fuchs Endothelial Corneal Dystrophy

What this Trial Is About

Researchers are comparing two types of cataract surgery, femtosecond laser-assisted cataract surgery FLACS and conventional phacoemulsification surgery CPS, in adults aged 40 and older who have moderate to severe Fuchs endothelial corneal dystrophy FECD along with cataracts. The goal is to find out which surgery better preserves corneal endothelial cells and leads to better visual outcomes and corneal clarity. This observational, multi-center study enrolls patients based on clinical need rather than random assignment. Participants will undergo either FLACS, involving laser-assisted corneal incisions, capsulotomy, and lens fragmentation followed by phacoemulsification, or CPS, which uses manual capsulorhexis and ultrasound energy for lens fragmentation. Before surgery, patients receive tests including visual acuity, corneal endothelial cell density in multiple zones, corneal thickness, and densitometry. Postoperative follow-ups occur at 1 day, 3 days, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years, with repeated assessments of endothelial cells, visual acuity, corneal thickness, and corneal clarity. During the study, participants will have comprehensive eye exams including intraocular pressure and refraction checks, plus specialized imaging to monitor corneal health. Researchers will measure changes in endothelial cell density and corneal thickness as primary outcomes. Secondary outcomes include visual acuity, corneal densitometry, corneal edema, and any complications. The study aims to guide surgical choices for patients with FECD and cataracts to improve long-term eye health, with total participation lasting about two years after surgery.

Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts