Comparing femtosecond laser-assisted versus conventional cataract surgery for people with Fuchs endothelial corneal dystrophy
Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts
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 |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Eye & ENT Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06966167 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.