Does a pre-operative subconjunctival injection of dexamethasone reduce the incidence of proliferative vitreoretinopathy in patients with ablatio retinae?
| ISRCTN | ISRCTN31308983 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31308983 |
| Protocol serial number | OZR-2001-09; NTR194 |
| Sponsor | Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (The Netherlands) |
| Funder | Foundation of Scientific Research at the Eye Hospital (Stichting Wetenschappelijk Onderzoek het Oogziekenhuis) (The Netherlands) |
- 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 |
|---|---|
| vanMeurs@oogziekenhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double blind, placebo controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Dexamethasone |
| Primary outcome measure(s) |
Incidence of proliferative vitreoretinopathy. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 22/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| 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
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 | 01/07/2010 | Yes | No |
