Effects of bimatoprost and latanoprost on ocular hemodynamics in normal tension glaucoma: a randomised trial

ISRCTN	ISRCTN18873428
DOI	https://doi.org/10.1186/ISRCTN18873428
Protocol serial number	1723427327/3
Sponsor	University Medical Center Hamburg-Eppendorf (Germany)
Funder	University Medical Center Hamburg-Eppendorf (Germany)

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

Martinistr. 52
Hamburg
20246
Germany

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Bimatoprost, latanoprost
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

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	Results	05/04/2005		Yes	No