Size Progression of Macular Degeneration After Cataract Surgery
Phase 4
Completed
- Conditions
- Age-Related Macular Degeneration
- Interventions
- Procedure: Cataract Surgery
- Registration Number
- NCT01165801
- Lead Sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Brief Summary
The purpose of this study was to find out if in patients with non-exudative age-related macular degeneration (AMD), randomly assigned to cataract surgery, any AMD size progression or progression to exudative AMD could be detected 6 months after surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 54
Inclusion Criteria
- Patients with cataract and non-exudative age-related macular degeneration
Exclusion Criteria
- Patients with retinal pathologies other than AMD, exudative AMD, progressive glaucoma, myopia > 10 diopters, panretinal laser treatment, former cataract or vitreoretinal surgery, were excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Group (CO) Cataract Surgery Fifty-four patients with cataract and non-exudative age-related macular degeneration (AMD) were randomized into an early surgery group (ES=28) with immediate cataract surgery and a control group (CO=26) where surgery was performed after six months.
- Primary Outcome Measures
Name Time Method AMD size (defined central region of interest) at enrollment, after 6 months To evaluate AMD size progression, absolute and relative differences in pixels of the ROI were cal-culated by equivalent tests.
- Secondary Outcome Measures
Name Time Method Functional ophthalmic assessments at enrollment, after 6 months Cataract grade (LOCS-III), Visual acuity (distance/near), contrast acuity tests, Visual Function Index (VF-14)
Trial Locations
- Locations (1)
The Rudolph Foundation Hospital, Dept. of Ophthalmology
🇦🇹Vienna, Austria