Effect of brimonidine, measured with the Nerve Fibre Analyser, in patients with acute ischaemic optic neuropathy
| ISRCTN | ISRCTN58221074 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58221074 |
| Protocol serial number | OZR-2000-07; NTR139 |
| 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 H G Lemij
Scientific
Scientific
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
| Phone | +31 (0)10 401 7777 |
|---|---|
| Lemij@oogziekenhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, double-blind, placebo controlled, parallel group, two-arm trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | AION |
| Study objectives | Administration of brimonidine eye drops in patients with acute ischaemic optic neuropathy (AION) reduces loss of vision. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Acute ischaemic optic neuropathy |
| Intervention | Topical treatment with brimonidine (0.5%) eye drops. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Brimonidine |
| Primary outcome measure(s) |
Thickness of peripapillary nerve fiber layer. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/08/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | Arteric or non-arteric AION |
| Key exclusion criteria | 1. Onset of symptoms greater than 5 days ago at presentation 2. Inability to undergo GDx or HFA measurement |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 01/08/2002 |
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 |
