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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorEye & ENT Hospital of Fudan University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: conventional phacoemulsification surgery (CPS)
Group B: femtosecond laser-assisted cataract surgery (FLACS)

Trial outcomes

Primary outcomes

1

Change in central corneal endothelial cell density (ECD) from baseline to postoperative time points

Time frame
From enrollment to the end of treatment at 2years
2

Change in corneal thickness from baseline to postoperative time points

Time frame
From enrollment to the end of treatment at 2years

Secondary outcomes

1

Change in corneal densitometry (central, superior, inferior, nasal, temporal zones)

Time frame
From enrollment to the end of treatment at 2years
2

Postoperative visual acuity outcomes (UDVA, CDVA)

Time frame
From enrollment to the end of treatment at 2years

Other outcomes

Sponsors and contacts

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