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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR839 |
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Date of registration:
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18/12/2006 |
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Primary sponsor: |
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Public title:
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Macula off rhegmatogenous retinal detachment and its functional recovery.
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Scientific title:
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Macula off rhegmatogenous retinal detachment and its functional recovery. - Rhegmatogenous retinal detachment, functional recovery |
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Date of first enrolment:
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1/2/2007 |
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Target sample size:
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200 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=839 |
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Study type:
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intervention |
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Study design:
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Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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L.I.
Los |
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Address:
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University Medical Center Groningen (UMCG),
Department of Ophthalmology
P.O. Box 30.001
9700 RB
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3612510 |
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Email:
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l.i.los@ohk.umcg.nl |
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Affiliation:
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Name:
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D.
Croonen |
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Address:
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University Medical Center Groningen (UMCG),
Department of Ophthalmology,
P.O. Box 30.001
Groningen
The Netherlands |
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Telephone:
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+31 (0)50 3612510 |
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Email:
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d.croonen@ohk.umcg.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Rhegmatogenous retinal detachment
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Intervention(s)
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Vitreoretinal surgery according to current practice guidelines.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN76474643
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N/A
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Source(s) of Monetary Support
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Stichting Nederlands Oogheelkundig Onderzoek
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