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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal control | Sham Comparator | Normal patient placebo |
|
| Glaucoma suspect | Sham Comparator | Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) |
|
| Newly diagnosed glaucoma | Experimental | Treated with Travoprost (0.04%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Oxygenation | For each subject, all the measurements will be done during an 1 hour appointment. | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Montreal | Montreal | Quebec | H3t1P1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Normal Control | Normal patient placebo placebo: Placebo |
| FG001 | Glaucoma Suspect | Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) placebo: Placebo |
| FG002 | Newly Diagnosed Glaucoma | Treated with Travoprost (0.04%) travoprost: Travatan Z is administered to newly diagnosed glaucoma patient |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Normal Control | Normal patient placebo placebo: Placebo |
| BG001 | Glaucoma Suspect | Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) placebo: Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Oxygenation | For each subject, all the measurements will be done during an 1 hour appointment. | Posted | Mean | 95% Confidence Interval | percentage of oxygenation | 1 hour |
|
6 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normal Control | Normal patient placebo placebo: Placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pierre Forcier | Université de Montreal | 514-343-7468 | pierre.forcier@umontreal.ca |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069557 | Travoprost |
| ID | Term |
|---|---|
| D003008 | Cloprostenol |
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
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| travoprost |
| Drug |
Travatan Z is administered to newly diagnosed glaucoma patient |
|
|
| BG002 | Newly Diagnosed Glaucoma | Treated with Travoprost (0.04%) travoprost: Travatan Z is administered to newly diagnosed glaucoma patient |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Glaucoma Suspect | Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) placebo: Placebo | 0 | 3 | 0 | 3 |
| EG002 | Newly Diagnosed Glaucoma | Treated with Travoprost (0.04%) travoprost: Travatan Z is administered to newly diagnosed glaucoma patient | 0 | 3 | 0 | 3 |
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| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |