Actively Recruiting
Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts
Led by Eye & ENT Hospital of Fudan University · Updated on 2025-06-17
120
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to compare the mid- to long-term efficacy of femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS) in patients with moderate to severe Fuchs' endothelial corneal dystrophy (FECD) complicated by cataracts. The main questions it aims to answer are: Does FLACS lead to better preservation of corneal endothelial cells compared to CPS in patients with moderate to severe FECD? How do visual outcomes and corneal transparency compare between FLACS and CPS in this patient population? Comparison Group: Researchers will compare patients undergoing FLACS with those undergoing CPS to evaluate differences in endothelial cell loss, corneal thickness, visual acuity, and corneal transparency. Participants: Adults aged 40 years and older diagnosed with moderate to severe FECD (endothelial cell density \<1500 cells/mm²). Patients scheduled for cataract surgery at participating centers. Participants will undergo: Preoperative evaluations, including visual acuity tests, corneal endothelial cell density assessment (central and five peripheral zones), corneal thickness, and corneal densitometry. Surgical intervention with either FLACS or CPS. Postoperative follow-ups at 1 day, 3 days, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years, including assessments of endothelial cell density, visual acuity, and corneal thickness. This study aims to provide evidence-based recommendations for optimizing surgical strategies in high-risk patients with FECD and cataracts.
CONDITIONS
Official Title
Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for cataract surgery
- Age 40 years or older
- Diagnosed with moderate to severe Fuchs' endothelial corneal dystrophy (FECD) with endothelial cell density less than 1500 cells/mm²
You will not qualify if you...
- History of prior intraocular surgery
- Presence of ocular conditions other than FECD and cataracts, such as severe dry eye, corneal scarring, keratoconus, uveitis, uncontrolled glaucoma, or vitreoretinal disease
- Requirement for additional intraocular procedures during the study period (excluding Nd:YAG posterior capsulotomy)
AI-Screening
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Trial Site Locations
Total: 1 location
1
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
J
Jin Yang
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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