Intravitreal dexamethasone treatment of bacterial endophthalmitis
| ISRCTN | ISRCTN77234772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77234772 |
| Protocol serial number | OZR-2001-18; NTR189 |
| 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
- 05/11/2008
- 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)10 401 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 | Intravitreal injection of vancomycin 0.2 mg, gentamycin 0.05 mg, and dexamethasone diphosphate 400 mg reduces tissue damage in patients with bacterial endophthalmitis. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Post-operative bacterial endophthalmitis |
| Intervention | Intravitreal injection of vancomycin 0.2 mg, gentamycin 0.05 mg, and dexamethasone diphosphate 400 mg or placebo. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Vancomycin, gentamycin, dexamethasone diphosphate |
| Primary outcome measure(s) |
Vision (ETDRS) after 3, 6 and 12 months, panbacterial polymerase chain reaction (PCR). |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 150 |
| Key inclusion criteria | 1. Post-cataract bacterial endophthalmitis 2. Strong, and increasing, irritation of anterior chamber and/or vitreous during post-operative 8 weeks interval |
| Key exclusion criteria | Antibiotics treatment |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 01/01/2005 |
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 |
