Does a pre-operative subconjunctival injection of dexamethasone reduce the incidence of proliferative vitreoretinopathy in patients with ablatio retinae?
ISRCTN | ISRCTN31308983 |
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DOI | https://doi.org/10.1186/ISRCTN31308983 |
Secondary identifying numbers | OZR-2001-09; NTR194 |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 04/11/2010
- 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 J C van Meurs
Scientific
Scientific
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
Phone | +31 (0)10 401 7777 |
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vanMeurs@oogziekenhuis.nl |
Study information
Study design | Randomised double blind, placebo controlled, parallel group trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Treatment |
Scientific title | |
Study objectives | A pre-operative subconjunctival injection of dexamethasone reduces the incidence of proliferative vitreoretinopathy in patients with ablatio retinae. |
Ethics approval(s) | Received from the local medical ethics committee |
Health condition(s) or problem(s) studied | Rhegmatogenous retinal detachment |
Intervention | Pre-operative and post-operative subconjunctival injection of dexamethasone (10 mg) or placebo. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | Dexamethasone |
Primary outcome measure | Incidence of proliferative vitreoretinopathy. |
Secondary outcome measures | No secondary outcome measures |
Overall study start date | 01/11/2002 |
Completion date | 22/01/2005 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Both |
Target number of participants | 40 (Study closed, analysis & publication in progress) |
Key inclusion criteria | 1. Primary rhegmatogenous retinal detachment 2. No previous ablation surgery |
Key exclusion criteria | 1. Diabetes mellitus 2. Systemic steroids 3. Steroid eye drops 4. Steroid glaucoma responder |
Date of first enrolment | 01/11/2002 |
Date of final enrolment | 22/01/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Oogziekenhuis Rotterdam
Rotterdam
3011 BH
Netherlands
3011 BH
Netherlands
Sponsor information
Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
Phone | +31 (0)10 401 77 77 |
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info@oogziekenhuis.nl | |
https://ror.org/02hjc7j46 |
Funders
Funder type
Research organisation
Foundation of Scientific Research at the Eye Hospital (Stichting Wetenschappelijk Onderzoek het Oogziekenhuis) (The Netherlands)
No information available
Results and Publications
Intention to publish date | |
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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 | 01/07/2010 | Yes | No |