European multicentre randomised controlled clinical trial: Heavy Silicone Oil (HSO) versus standard silicone oil as long term vitreous tamponade
| ISRCTN | ISRCTN47399029 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47399029 |
| Protocol serial number | OZR-2004-06; NTR185 |
| 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
- 14/07/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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 4017777 |
|---|---|
| vanMeurs@oogziekenhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | HSO-Study |
| Study objectives | Efficacies of heavy silicone oil and of standard silicone oil, as long-term vitreous tamponade in patients with complex ablatio retinae, are equivalent. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee before participants were recruited |
| Health condition(s) or problem(s) studied | Retinal detachment, proliferative vitreoretinopathy |
| Intervention | Randomised to: 1. Heavy silicone oil, or 2. Standard silicone oil As long-term vitreous tamponade. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Heavy silicone oil, standard silicone oil |
| Primary outcome measure(s) |
Complete retinal reattachment and Early Treatment Diabetic Retinopathy Study (ETDRS) vision after 12 months. |
| Key secondary outcome measure(s) |
Number of resurgeries within 12 months |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 80 |
| Key inclusion criteria | 1. Ablatio retinae with proliferative vitreoretinopathy (PVR) 2. Giant tear below 10 - 12 hours |
| Key exclusion criteria | 1. Defects above 10 - 12 hours 2. Proliferative diabetic retinopathy 3. Trauma 4. Uveitis 5. Glaucoma 6. Monoculus |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/05/2007 |
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 |
