Corneal densitometry measurements comparison between anterior segment OCT and scheimpflug imaging.
Enrico Lupardi, Antonio Moramarco, Federico Cassini...
https://pubmed.ncbi.nlm.nih.gov/39320570Actively Recruiting
Age: 40Years +
All Genders
ID06966167
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
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing two types of cataract surgery, femtosecond laser-assisted cataract surgery (FLACS) and conventional phacoemulsification surgery (CPS), in adults aged 40 and older who have moderate to severe Fuchs' endothelial corneal dystrophy (FECD) along with cataracts. The goal is to find out which surgery better preserves corneal endothelial cells and leads to better visual outcomes and corneal clarity. This observational, multi-center study enrolls patients based on clinical need rather than random assignment. Participants will undergo either FLACS, involving laser-assisted corneal incisions, capsulotomy, and lens fragmentation followed by phacoemulsification, or CPS, which uses manual capsulorhexis and ultrasound energy for lens fragmentation. Before surgery, patients receive tests including visual acuity, corneal endothelial cell density in multiple zones, corneal thickness, and densitometry. Postoperative follow-ups occur at 1 day, 3 days, 1 week, 1 month, 3 months, 6 months, 1 year, and 2 years, with repeated assessments of endothelial cells, visual acuity, corneal thickness, and corneal clarity. During the study, participants will have comprehensive eye exams including intraocular pressure and refraction checks, plus specialized imaging to monitor corneal health. Researchers will measure changes in endothelial cell density and corneal thickness as primary outcomes. Secondary outcomes include visual acuity, corneal densitometry, corneal edema, and any complications. The study aims to guide surgical choices for patients with FECD and cataracts to improve long-term eye health, with total participation lasting about two years after surgery.
CONDITIONS
Brief 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
You may qualify if you...
- Patients scheduled for cataract surgery
- Age 40 years or older
- Diagnosed with moderate to severe Fuchs' endothelial corneal dystrophy with endothelial cell density less than 1500 cells/mm�b2
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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery and Immediate Post-operative Care
Duration - 1 day to 1 week
Participants undergo either femtosecond laser-assisted cataract surgery or conventional phacoemulsification surgery, followed by immediate postoperative assessments.
3 visits (1 day, 3 days, and 1 week post-surgery, in-person)
Post-operative Follow-up
Duration - Up to 2 years
Participants attend follow-up visits to monitor visual acuity, corneal endothelial health, and other eye parameters to assess surgery outcomes.
5 visits (1 month, 3 months, 6 months, 1 year, and 2 years post-surgery, in-person)
Trial Site Locations
Total: 1 location
1
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
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Research Team
J
Jin Yang
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
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Published Research Related To This Trial
Global Prevalence of Fuchs Endothelial Corneal Dystrophy (FECD) in Adult Population: A Systematic Review and Meta-Analysis.
Francesco Aiello, Gabriele Gallo Afflitto, Francesca Ceccarelli...
https://pubmed.ncbi.nlm.nih.gov/35462618Fuchs Dystrophy and Cataract: Diagnosis, Evaluation and Treatment.
Muhammad Ali, Kyongjin Cho, Divya Srikumaran
https://pubmed.ncbi.nlm.nih.gov/36637659Central corneal endothelial cell changes over a ten-year period.
W M Bourne, L R Nelson, D O Hodge
https://pubmed.ncbi.nlm.nih.gov/9071233