Contact information
Type
Scientific
Primary contact
Dr D Croonen
ORCID ID
Contact details
University Medical Center Groningen (UMCG)
Department of Ophthalmology
P.O. Box 30.001
Groningen
-
Netherlands
+31 (0)50 361 2510
d.croonen@ohk.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study 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.
Ethics approval
Approval received from the local ethics committee (Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen [METc UMCG]) on the 11th July 2006 (ref: 12551).
Study design
Non-randomised prospective observational study
Primary study design
Observational
Secondary study design
Case-control study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Condition
Rhegmatogenous retinal detachment
Intervention
Vitreoretinal surgery according to current practice guidelines.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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, duration and height of macular detachment
Primary study group:
Pre-operative and postoperative at one, three, six and 12 months.
Secondary study group:
Pre-operative and one year after the latest vitreoretinal surgery.
Secondary outcome measures
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
Overall trial start date
01/02/2007
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant inclusion criteria
Primary study group:
1. Rhegmatogenous retinal detachment with macula off during one day to six weeks
2. Retinal reattachment after one surgical intervention
3. No redetachment during the study period (one year)
Secondary study group:
Same as primary study group, but more than one vitreoretinal surgical procedure is needed to obtain retinal attachment.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200
Participant 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
Recruitment start date
01/02/2007
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Groningen
-
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (UMCG) (The Netherlands)
Sponsor details
Department of Ophtalmology
P.O. Box 30001
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Dutch Foundation of Ophthalmologic Research (Stichting Nederlands Oogheelkundig Onderzoek) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary