Ibopamine 2% eye drops in the treatment of patients with ocular hypotony after vitreoretinal surgery for retinal detachment or uveitis: results after six months of treatment
| ISRCTN | ISRCTN46178243 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46178243 |
| Protocol serial number | OZR-2003-16 |
| 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
- 12/04/2021
- 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 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 | Non-randomised trial |
| Secondary study design | Non randomised controlled trial |
| Scientific title | Ibopamine 2% eye drops in the treatment of patients with ocular hypotony after vitreoretinal surgery for retinal detachment or uveitis: results after six months of treatment |
| Study objectives | Long-term administration of Ibopamine hydrochloride eye drops restores and maintains intraocular pressure in patients with hypotony following vitreoretinal surgery for ablatio reinae, or uveitis. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ocular hypotony following either vitreoretinal surgery or uveitis |
| Intervention | Long-term topical treatment with Ibopamine (2%) eye drops. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ibopamine |
| Primary outcome measure(s) |
1. Ocular pressure |
| Key secondary outcome measure(s) |
1. Position of silicone oil (after surgery) |
| Completion date | 01/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 21 |
| Total final enrolment | 17 |
| Key inclusion criteria | 1. Hypotony (0-5 mm Hg) 2. Stable eye pressure for at least 4 months 3. No reaction of eye pressure to atropine and steroids 4. Continued steroid treatment during past six months 5. Status after vitreoretinal surgery or uveitis |
| Key exclusion criteria | 1. Chronic heart failure 2. Hypotony caused by other factors than surgery or uveitis 3. Traction on corpus ciliare 4. Cyclodialysis |
| Date of first enrolment | 01/03/2004 |
| Date of final enrolment | 01/03/2006 |
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 | 01/04/2012 | 12/04/2021 | Yes | No |
Editorial Notes
12/04/2021: Publication reference and total final enrolment added.
