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
Scientific
University Medical Center Groningen (UMCG)
Department of Ophthalmology
P.O. Box 30.001
Groningen
-
Netherlands
Phone | +31 (0)50 361 2510 |
---|---|
d.croonen@ohk.umcg.nl |
Study information
Study design | Non-randomised prospective observational study |
---|---|
Primary study design | Observational |
Secondary study design | Case-control study |
Study setting(s) | Other |
Study type | Treatment |
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 | 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 study start date | 01/02/2007 |
Completion date | 31/12/2011 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Not Specified |
Sex | Not Specified |
Target number of participants | 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
-
Netherlands
Sponsor information
University Medical Center Groningen (UMCG) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Ophtalmology
P.O. Box 30001
Groningen
9700 RB
Netherlands
Website | http://www.umcg.nl/azg/nl/english/azg/ |
---|---|
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 share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | 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.