Fuchs' Endothelial Dystrophy Clinical Trial
Official title:
Fuchs' Endothelial Dystrophy and Cataract Surgery: Can Torsional Phacoemulsification Decrease the Risk for Corneal Decompensation
The primary objective is to compare the effect of torsional phacoemulsification and longitudinal phacoemulsification on central and peripheral corneal thickness/volume after cataract surgery in patients with Fuchs' endothelial dystrophy.
Status | Completed |
Enrollment | 50 |
Est. completion date | |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 95 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed with Fuchs' endothelial dystrophy (all stages) and planning to undergo cataract surgery due to visually significant cataract - Patients should be 40 years of age or older Exclusion Criteria: - Patients with Fuchs' dystrophy with a history of previous corneal or intraocular surgery - Patients with a planned combined surgical procedure - Patients who have other vision-affecting disorders than Fuchs' endothelial dystrophy |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | University Hospital Maastricht | Maastricht |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in central corneal thickness/corneal volume | 1, 7 days and 1 , 3 and 6 months postoperatively | Yes | |
Secondary | Changes in BCVA | 1, 7 days and 1, 3 and 6 months postoperatively | No |
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