NCT06966167 Comparison of Outcomes Between Femtosecond Laser-Assisted and Conventional Phacoemulsification in Fuchs Endothelial Corneal Dystrophy Patients With Cataracts
| NCT ID | NCT06966167 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Fuchs Endothelial Corneal Dystrophy |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-01 |
| Primary Completion | 2030-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2025-01-01 with a primary completion date of 2030-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06966167 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Fuchs Endothelial Corneal Dystrophy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06966167 currently recruiting?
Yes, NCT06966167 is actively recruiting participants. Contact the research team at jin_er76@hotmail.com for enrollment information.
Where is the NCT06966167 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06966167 clinical trial?
NCT06966167 is sponsored by Eye & ENT Hospital of Fudan University. The trial plans to enroll 120 participants.