Macula off rhegmatogenous retinal detachment and its functional recovery

ISRCTN	ISRCTN76474643
DOI	https://doi.org/10.1186/ISRCTN76474643
Protocol serial number	NL826, NTR839
Sponsor	University Medical Center Groningen (UMCG) (The Netherlands)
Funder	Dutch Foundation of Ophthalmologic Research (Stichting Nederlands Oogheelkundig Onderzoek) (The Netherlands)

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

Primary study design	Observational
Study design	Non-randomised prospective observational study
Secondary study design	Case-control study
Scientific title	Macula off rhegmatogenous retinal detachment and its functional recovery
Study objectives	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(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) studied	Rhegmatogenous retinal detachment
Intervention	Vitreoretinal surgery according to current practice guidelines.
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2011

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	200
Total final enrolment	45
Key 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.
Key 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
Date of first enrolment	01/02/2007
Date of final enrolment	31/12/2011

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen (UMCG)

Groningen
-
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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.