Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD
Not Applicable
Completed
- Conditions
- Age-Related Macular Degeneration
- Registration Number
- NCT00401713
- Lead Sponsor
- The Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery
- Brief Summary
The purpose of this study is to evaluate two surgical interventions in patients with AMD.
- Detailed Description
The Submacular surgical trials have shown that submacular membrane extraction alone did not improve or preserve visual acuity in patients with AMD. Transplantation of autologous RPE and translocation of autologous RPE and choroid represent two promising therapeutic interventions in patients with AMD. This prospective, randomized clinical trial compares the two surgical treatments and additionally compares the clinical results (visual acuity, FLA) with OCT- and UHR-OCT data.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- AMD and submacular cnv
- non responders to laser treatment or pdt
- treatment: rpe transplantation or rpe + choroid translocation
- age over 50 years
Exclusion Criteria
- other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases.
- optic atrophy
- unstable glaucoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Visual Acuity: distance and near preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months FLA (preoperatively, 3 months, +/- 12 months after surgery)
- Secondary Outcome Measures
Name Time Method OCT (preoperatively, 3 months, 12 months after surgery) UHR OCT (after surgery, including silicone oil removal) autofluorescence (preoperatively, 3 months, +/- 12 months after surgery) perimetry (if feasible)
Trial Locations
- Locations (1)
Department of Opthalmology, Rudolf Foundation Clinic
🇦🇹Vienna, Austria