Condition category
Eye Diseases
Date applied
09/03/2005
Date assigned
21/03/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Oliver Zeitz

ORCID ID

Contact details

Martinistr. 52
Hamburg
20246
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1723427327/3

Study information

Scientific title

Acronym

Study hypothesis

It is hypothesised that locally applied prostaglandins improve ocular haemodynamics in normal tension glaucoma patients.

Ethics approval

The study was performed in accordance to institutional, national, and international guidelines and was approved by the local ethics committee.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Normal tension glaucoma

Intervention

Administration of latanoprost or bimatoprost eye drops.

Intervention type

Drug

Phase

Not Specified

Drug names

Bimatoprost, latanoprost

Primary outcome measures

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 trial start date

01/01/2003

Overall trial end date

31/12/2003

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Treated open angle glaucoma
2. Intraocular pressure greater than 21
3. Non-compliance

Recruitment start date

01/01/2003

Recruitment end date

31/12/2003

Locations

Countries of recruitment

Germany

Trial participating centre

Martinistr. 52
Hamburg
20246
Germany

Sponsor information

Organisation

University Medical Center Hamburg-Eppendorf (Germany)

Sponsor details

Martinistr. 52
Hamburg
D-20246
Germany

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University Medical Center Hamburg-Eppendorf (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/15811188

Publication citations

  1. Results

    Zeitz O, Matthiessen ET, Reuss J, Wiermann A, Wagenfeld L, Galambos P, Richard G, Klemm M, Effects of glaucoma drugs on ocular hemodynamics in normal tension glaucoma: a randomized trial comparing bimatoprost and latanoprost with dorzolamide [ISRCTN18873428]., BMC Ophthalmol, 2005, 5, 6, doi: 10.1186/1471-2415-5-6.

Additional files

Editorial Notes