Actively Recruiting

Age: 40Years +
All Genders
NCT06966167

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

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Eye and ENT hospital of Fudan University

Shanghai, Shanghai Municipality, China, 200000

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

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