Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma

Primary Open Angle Glaucoma Clinical Trial

Official title:

Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01711177
• Other study ID #: OPM3117-Dubois/Pham
• 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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma

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