Macula off rhegmatogenous retinal detachment and its functional recovery

ISRCTN ISRCTN76474643
DOI https://doi.org/10.1186/ISRCTN76474643
Secondary identifying numbers NL826, NTR839
Submission date
16/01/2007
Registration date
16/01/2007
Last edited
14/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D Croonen
Scientific

University Medical Center Groningen (UMCG)
Department of Ophthalmology
P.O. Box 30.001
Groningen
-
Netherlands

Phone +31 (0)50 361 2510
Email d.croonen@ohk.umcg.nl

Study information

Study designNon-randomised prospective observational study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Other
Study typeTreatment
Scientific titleMacula off rhegmatogenous retinal detachment and its functional recovery
Study objectivesOptimum 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(s)Approval received from the local ethics committee (Medisch Ethische Toetsingscommissie Universitair Medisch Centrum Groningen [METc UMCG]) on the 11th July 2006 (ref: 12551).
Health condition(s) or problem(s) studiedRhegmatogenous retinal detachment
InterventionVitreoretinal surgery according to current practice guidelines.
Intervention typeOther
Primary outcome measure1. 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 measures1. 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 study start date01/02/2007
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants200
Total final enrolment45
Key inclusion criteriaPrimary 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.
Key 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
Date of first enrolment01/02/2007
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Netherlands

Study participating centre

University Medical Center Groningen (UMCG)
Groningen
-
Netherlands

Sponsor information

University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre

Department of Ophtalmology
P.O. Box 30001
Groningen
9700 RB
Netherlands

Website http://www.umcg.nl/azg/nl/english/azg/
ROR logo "ROR" https://ror.org/03cv38k47

Funders

Funder type

Research organisation

Dutch Foundation of Ophthalmologic Research (Stichting Nederlands Oogheelkundig Onderzoek) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 13/06/2014 14/01/2021 Yes No

Editorial Notes

14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.