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Clinical Trials/NCT01711177
NCT01711177CompletedNot Applicable

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

Université de Montréal1 site in 1 country14 target enrollmentStarted: October 2012Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Locations
1
Primary Endpoint
Blood Oxygenation

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
45 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Newly diagnosed glaucoma

Experimental

Treated with Travoprost (0.04%)

Intervention: travoprost (Drug)

Normal control

Sham Comparator

Normal patient placebo

Intervention: placebo (Drug)

Glaucoma suspect

Sham Comparator

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

Intervention: placebo (Drug)

Outcomes

Primary Outcomes

Blood Oxygenation

Time Frame: 1 hour

For each subject, all the measurements will be done during an 1 hour appointment.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Pierre Forcier

Associate professor

Université de Montréal

Study Sites (1)

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