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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01711177
First Posted: October 22, 2012
Last Update Posted: July 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pierre Forcier, Université de Montréal
  Purpose

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


Condition Intervention
Primary Open Angle Glaucoma Drug: placebo Drug: travoprost

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Travoprost 0.004% on Retinal Oximetry in Primary Open Angle Glaucoma

Resource links provided by NLM:


Further study details as provided by Pierre Forcier, Université de Montréal:

Primary Outcome Measures:
  • Blood Oxygenation [ Time Frame: 1 hour ]
    For each subject, all the measurements will be done during an 1 hour appointment.


Enrollment: 14
Study Start Date: October 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: Normal control
Normal patient placebo
Drug: placebo
Placebo
Sham Comparator: Glaucoma suspect
Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
Drug: placebo
Placebo
Experimental: Newly diagnosed glaucoma
Treated with Travoprost (0.04%)
Drug: travoprost
Travatan Z is administered to newly diagnosed glaucoma patient
Other Name: travatan

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01711177


Locations
Canada, Quebec
University of Montreal
Montreal, Quebec, Canada, H3t1P1
Sponsors and Collaborators
Université de Montréal
  More Information

Responsible Party: Pierre Forcier, Associate professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01711177     History of Changes
Other Study ID Numbers: OPM3117-Dubois/Pham
First Submitted: October 3, 2012
First Posted: October 22, 2012
Results First Submitted: June 16, 2016
Results First Posted: July 28, 2016
Last Update Posted: July 28, 2016
Last Verified: June 2016

Keywords provided by Pierre Forcier, Université de Montréal:
primary open angle glaucoma
retinal oximetry

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases
Travoprost
Antihypertensive Agents