Comparing femtosecond laser-assisted versus conventional cataract surgery for people with Fuchs endothelial corneal dystrophy
Official title: Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts
Run by Eye & ENT Hospital of Fudan University · NCT06966167 · Data updated 2026-11-12
This study will test whether femtosecond laser-assisted cataract surgery or conventional phacoemulsification better preserves corneal endothelial cells and vision in adults with moderate to severe Fuchs endothelial corneal dystrophy who need cataract surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | January 1, 2025 |
| Main results expected | January 2030 |
| Study ends | January 2030 |
| Registry record updated | June 17, 2025 |
| Trial ID | NCT06966167 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40 years or older with moderate to severe Fuchs endothelial corneal dystrophy (ECD <1500 cells/mm²) who are scheduled for cataract surgery and have no other major ocular comorbidities are ideal candidates.
✕Probably not a fit
Patients with prior intraocular surgery, other significant eye diseases, or who require additional intraocular procedures are unlikely to benefit from this study's comparisons.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, observational, controlled comparison of femtosecond laser-assisted cataract surgery (FLACS) versus conventional phacoemulsification surgery (CPS) in patients with moderate to severe Fuchs endothelial corneal dystrophy undergoing cataract extraction. Participants are adults aged 40 and older with endothelial cell density below 1500 cells/mm² who are scheduled for cataract surgery and meet exclusion criteria. Primary outcomes include endothelial cell density loss and corneal thickness changes, with secondary outcomes such as visual acuity and corneal transparency tracked over the mid- to long-term postoperative period. The study is run at the Eye & ENT Hospital of Fudan University with standardized measurements and comparison between the two surgical groups.
Why it matters
Potential benefit: If successful, the findings could help surgeons choose the cataract technique that best preserves corneal endothelium and reduces the risk of corneal decompensation in FECD patients.
How similar studies have gone: Previous studies in general cataract populations have shown mixed or modest endothelial-sparing advantages for FLACS, but evidence specific to moderate-to-severe FECD is limited and not definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for cataract surgery * Age ≥40 years * Diagnosed with moderate to severe FECD (endothelial cell density \<1500 cells/mm²) Exclusion Criteria: * 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)
Where it's running
-
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Jin Yang
- Email: jin_er76@hotmail.com
- Phone: +86 021-64377134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.