| - candidate number | 2371 |
| - NTR Number | NTR839 |
| - ISRCTN | ISRCTN76474643 |
| - Date ISRCTN created | 16-jan-2007 |
| - date ISRCTN requested | 29-dec-2006 |
| - Date Registered NTR | 18-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | Macula off rhegmatogenous retinal detachment and its functional recovery. |
| - Scientific Title | Macula off rhegmatogenous retinal detachment and its functional recovery. |
| - ACRONYM | Rhegmatogenous retinal detachment, functional recovery |
| - hypothesis | Optimum timing of surgery for macula off rhegmatogenous retinal detachment can be determined in more detail by taking both duration and height of macular detachment into account. |
| - Healt Condition(s) or Problem(s) studied | Rhegmatogenous retinal detachment |
| - Inclusion criteria | Primary study group: 1. Rhegmatogenous retinal detachment with macula off during 1 day to 6 weeks; 2. Retinal reattachment after one surgical intervention; 3. No redetachment during the study period (1 year). Secondary study group: same as primary study group, but more than one vitreoretinal surgical procedure is needed to obtain retinal attachment. |
| - Exclusion criteria | 1. Pre-existent ocular pathology in the study or fellow eye that significantly influences visual acuity; 2. History of retinal detachment in the study or fellow eye. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-feb-2007 |
| - planned closingdate | 31-dec-2011 |
| - Target number of participants | 200 |
| - Interventions | Vitreoretinal surgery according to current practice guidelines. |
| - Primary outcome | 1. Visual acuity in relation to duration and height of macular detachment; 2. Individual parameters relating to visual function, subjective contentness and morphology of the macula in relation to each other. Primary study group: Pre-operative and postoperative at 1, 3, 6 and 12 months. Secundary study group: Pre-operative and 1 year after the latest vitreoretinal surgery. |
| - Secondary outcome | 1. Correlation between height macular detachment measured by ultrasonography and by optical coherence tomography. 2. Relationship between subjective contentness in the primary and secondary study groups. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Drs. D. Croonen |
| - CONTACT for SCIENTIFIC QUERIES | Dr. L.I. Los |
| - Sponsor/Initiator | University Medical Center Groningen (UMCG), Department Ophtalmology |
| - Funding (Source(s) of Monetary or Material Support) | Stichting Nederlands Oogheelkundig Onderzoek |
| - Publications | N/A |
| - Brief summary | A rhegmatogenous retinal detachment is a condition that can severly affect visual function, in particular when the macula is involved in the detachment. Previous studies evaluated whether duration of macular detachment or height of macular detachment influenced postoperative visual prognosis. Both factors - taken separately - are of importance, however when looking at duration of macular detachment no significant differences in visual recovery were observed between eyes with macular detachment of 1 to 9 days. The present study will evaluate whether differences in visual recovery can be related more strictly to duration of macular detachment when the data are corrected for height of macular detachment. This may result in a recommendation to change current practice with regard to patient scheduling in vitreoretinal surgery for rhegmatogenous retinal detachment. |
| - Main changes (audit trail) | |
| - RECORD | 18-dec-2006 - 27-feb-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl