Primary Open Angle Glaucoma
Conditions
Keywords
primary open angle glaucoma, retinal oximetry
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
Interventions
DRUGplacebo
Placebo
DRUGtravoprost
Travatan Z is administered to newly diagnosed glaucoma patient
Sponsors
Université de Montréal
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood Oxygenation | 1 hour | For each subject, all the measurements will be done during an 1 hour appointment. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Normal Control Normal patient placebo
placebo: Placebo | 10 |
| Glaucoma Suspect Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)
placebo: Placebo | 3 |
| Newly Diagnosed Glaucoma Treated with Travoprost (0.04%)
travoprost: Travatan Z is administered to newly diagnosed glaucoma patient | 3 |
| Total | 16 |
Baseline characteristics
| Characteristic | Total | Normal Control | Glaucoma Suspect | Newly Diagnosed Glaucoma |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 10 Participants | 3 Participants | 2 Participants |
| Age, Continuous | 55 years STANDARD_DEVIATION 10 | 50 years STANDARD_DEVIATION 5 | 53 years STANDARD_DEVIATION 8 | 60 years STANDARD_DEVIATION 9 |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 5 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 10 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Blood Oxygenation
For each subject, all the measurements will be done during an 1 hour appointment.
Time frame: 1 hour
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Normal Control | Blood Oxygenation | 60 percentage of oxygenation |
| Glaucoma Suspect | Blood Oxygenation | 60 percentage of oxygenation |
| Newly Diagnosed Glaucoma | Blood Oxygenation | 60 percentage of oxygenation |