Status:

RECRUITING

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

Lead Sponsor:

Eye & ENT Hospital of Fudan University

Conditions:

Fuchs Endothelial Corneal Dystrophy

Cataract

Eligibility:

All Genders

40+ years

Brief Summary

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 ...

Detailed Description

Fuchs' endothelial corneal dystrophy (FECD) is a progressive, bilateral corneal disorder characterized by endothelial cell loss, Descemet's membrane thickening, and corneal edema, leading to visual im...

Eligibility Criteria

Inclusion

  • Patients scheduled for cataract surgery
  • Age ≥40 years
  • Diagnosed with moderate to severe FECD (endothelial cell density \<1500 cells/mm²)

Exclusion

  • 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)

Key Trial Info

Start Date :

January 1 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2030

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT06966167

Start Date

January 1 2025

End Date

January 1 2030

Last Update

June 17 2025

Active Locations (1)

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Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200000