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van CCT (UK)


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van CCT (UK)


Macula off rhegmatogenous retinal detachment and its functional recovery.


- candidate number2371
- NTR NumberNTR839
- ISRCTNISRCTN76474643
- Date ISRCTN created16-jan-2007
- date ISRCTN requested29-dec-2006
- Date Registered NTR18-dec-2006
- Secondary IDsN/A 
- Public TitleMacula off rhegmatogenous retinal detachment and its functional recovery.
- Scientific TitleMacula off rhegmatogenous retinal detachment and its functional recovery.
- ACRONYMRhegmatogenous retinal detachment, functional recovery
- hypothesisOptimum 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) studiedRhegmatogenous retinal detachment
- Inclusion criteriaPrimary 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 criteria1. 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 receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-feb-2007
- planned closingdate31-dec-2011
- Target number of participants200
- InterventionsVitreoretinal surgery according to current practice guidelines.
- Primary outcome1. 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 outcome1. 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 siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. D. Croonen
- CONTACT for SCIENTIFIC QUERIESDr. L.I. Los
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department Ophtalmology
- Funding
(Source(s) of Monetary or Material Support)
Stichting Nederlands Oogheelkundig Onderzoek
- PublicationsN/A
- Brief summaryA 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)
- RECORD18-dec-2006 - 27-mrt-2014


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