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

NCT ID: NCT01711177

Last Updated: 2016-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-03-31

Brief 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

Conditions

Primary Open Angle Glaucoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Normal control

Normal patient placebo

Group Type: SHAM_COMPARATOR

placebo

Intervention Type: DRUG

Placebo

Glaucoma suspect

Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)

Group Type: SHAM_COMPARATOR

placebo

Intervention Type: DRUG

Placebo

Newly diagnosed glaucoma

Treated with Travoprost (0.04%)

Group Type: EXPERIMENTAL

travoprost

Intervention Type: DRUG

Travatan Z is administered to newly diagnosed glaucoma patient

Interventions

placebo

Placebo

Intervention Type: DRUG

travoprost

Travatan Z is administered to newly diagnosed glaucoma patient

Intervention Type: DRUG

Other Intervention Names

travatan

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Université de Montréal

OTHER

Sponsor Role: lead

Responsible Party

Pierre Forcier

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Montreal

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

OPM3117-Dubois/Pham

Identifier Type: -

Identifier Source: org_study_id