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The purpose of this study is to evaluate two surgical interventions in patients with AMD.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transplantation of autologous RPE | Procedure | RPE cell suspension | ||
| Translocation of autologous RPE and Choroid | Procedure | RPE patch |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity: distance and near | preoperatively, 1 months, 3 months, 12 months, +/- 18 months, 36 months | |
| FLA | (preoperatively, 3 months, +/- 12 months after surgery) |
| Measure | Description | Time Frame |
|---|---|---|
| OCT | (preoperatively, 3 months, 12 months after surgery) | |
| UHR OCT | (after surgery, including silicone oil removal) | |
| autofluorescence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Binder, MD | Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery, Department of Ophthalmology, Rudolf Foundation Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Opthalmology, Rudolf Foundation Clinic | Vienna | State of Vienna | 1030 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | van Meurs JC et al Br J opthalmol 2004; 88:110-113 | ||
| 14516809 | Background | van Meurs JC, Van Den Biesen PR. Autologous retinal pigment epithelium and choroid translocation in patients with exudative age-related macular degeneration: short-term follow-up. Am J Ophthalmol. 2003 Oct;136(4):688-95. doi: 10.1016/s0002-9394(03)00384-2. | |
| 20610478 |
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| (preoperatively, 3 months, +/- 12 months after surgery) |
| perimetry | (if feasible) |
| Derived |
| Falkner-Radler CI, Krebs I, Glittenberg C, Povazay B, Drexler W, Graf A, Binder S. Human retinal pigment epithelium (RPE) transplantation: outcome after autologous RPE-choroid sheet and RPE cell-suspension in a randomised clinical study. Br J Ophthalmol. 2011 Mar;95(3):370-5. doi: 10.1136/bjo.2009.176305. Epub 2010 Jul 7. |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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