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

NCT06966167 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2025-06-17

No results posted yet for this study

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 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

  • Fuchs Endothelial Corneal Dystrophy
  • Cataract

Sponsors & Collaborators

  • Eye & ENT Hospital of Fudan University

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2030-01-31
Completion
2030-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06966167 on ClinicalTrials.gov