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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01711177
Other study ID # OPM3117-Dubois/Pham
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 3, 2012
Last updated October 19, 2012
Start date October 2012
Est. completion date March 2013

Study information

Verified date October 2012
Source Université de Montréal
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

Glaucoma is the second leading cause of blindness among seniors in Canada. It is often associated with an elevated intraocular pressure (IOP), but its exact mechanism is still largely unknown. Some studies have shown a link between glaucoma and changes in the amount of oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular veins among three different groups using a spectrophotometer. This instrument is linked to a camera and can measure the quantity of oxygen in the veins using different characteristics of the blood inside.

The groups of the study are: patients without glaucoma, patients suspected of glaucoma and patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost 0.004%, will only be administered to the groups suspected or diagnosed with glaucoma. Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten patients will be recruited into each group for a total of 30 patients in this study. All patients for the suspected or diagnosed groups will be recruited from the Jewish General Hospital. Subsequently all testing will be done at the École d'optométrie, Université de Montréal


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 45 Years to 80 Years
Eligibility Inclusion Criteria:

- good systemic health

- irido-corneal angle open

- intraocular pressure more than 18 mmHg

Exclusion Criteria:

- having cardiovascular problem

- Hypertension or diabetes

- under systemic medication for high blood pressure

- had an ocular surgery in the past

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
placebo
Placebo
travoprost
Travatan Z is administered to newly diagnosed glaucoma patient

Locations

Country Name City State
Canada University of Montreal Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Montréal

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood oxygenation For each subject, all the measurements will be done during an 1 hour appointment. 1 hour No
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