Effects of bimatoprost and latanoprost on ocular hemodynamics in normal tension glaucoma: a randomised trial
| ISRCTN | ISRCTN18873428 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18873428 |
| Secondary identifying numbers | 1723427327/3 |
- Submission date
- 09/03/2005
- Registration date
- 21/03/2005
- Last edited
- 18/02/2008
- 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 Oliver Zeitz
Scientific
Scientific
Martinistr. 52
Hamburg
20246
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | It is hypothesised that locally applied prostaglandins improve ocular haemodynamics in normal tension glaucoma patients. |
| Ethics approval(s) | The study was performed in accordance to institutional, national, and international guidelines and was approved by the local ethics committee. |
| Health condition(s) or problem(s) studied | Normal tension glaucoma |
| Intervention | Administration of latanoprost or bimatoprost eye drops. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Bimatoprost, latanoprost |
| Primary outcome measure | Ocular perfusion is assessed by Doppler imaging. Primary endpoints are the peak systolic velocity (PSV) and end-diastolic velocity (EDV) in the short posterior ciliary artery. |
| Secondary outcome measures | Secondary endpoints are: 1. The PSV and EDV in: 1.1. The long posterior ciliary artery, 1.2. The central retinal artery, and 1.3. The ophthalmic artery 2. Resistivity index, pulsatility index and time average velocity (maximum and mean) in all four vessels 3. Intraocular pressure |
| Overall study start date | 01/01/2003 |
| Completion date | 31/12/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key inclusion criteria | Progressive normal tension glaucoma patients. Progression was defined as progressive excavation of the optic disc (funduscopic and controlled by the Heidelberg retina tomography [HRT]) and/or progressive visual field loss in the Humphrey perimeter over the last 6 - 12 months. |
| Key exclusion criteria | 1. Treated open angle glaucoma 2. Intraocular pressure greater than 21 3. Non-compliance |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/12/2003 |
Locations
Countries of recruitment
- Germany
Study participating centre
Martinistr. 52
Hamburg
20246
Germany
20246
Germany
Sponsor information
University Medical Center Hamburg-Eppendorf (Germany)
University/education
University/education
Martinistr. 52
Hamburg
D-20246
Germany
"ROR" |
https://ror.org/01zgy1s35 |
|---|
Funders
Funder type
University/education
University Medical Center Hamburg-Eppendorf (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 | 05/04/2005 | Yes | No |
