About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients scheduled for cataract surgery
Age ≥40 years
Diagnosed with moderate to severe FECD (endothelial cell density <1500 cells/mm²)
Disqualifiers
History of prior intraocular surgery
Presence of ocular conditions other than FECD and cataracts (e.g., severe dry eye, corneal scarring, keratoconus, uveitis, uncontrolled glaucoma, vitreoretinal disease)
Requirement for additional intraocular procedures during the study period (excluding Nd:YAG posterior capsulotomy)
Trial population
Participants aged 40 years or older, diagnosed with moderate to severe Fuchs endothelial corneal dystrophy (endothelial cell density \< 1500 cells/mm²), and presenting with visually significant cataract.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in central corneal endothelial cell density (ECD) from baseline to postoperative time points
Change in corneal thickness from baseline to postoperative time points
Secondary outcomes
Change in corneal densitometry (central, superior, inferior, nasal, temporal zones)
Postoperative visual acuity outcomes (UDVA, CDVA)
Sponsors and contacts
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