Glaucoma, Open-Angle Clinical Trial
Official title:
The Effect of Ginkgo Biloba on Ocular Blood Flow in Primary Open-Angle Glaucoma Patients: A Double-Blind Randomized Crossover Trial
Verified date | February 2015 |
Source | Maisonneuve-Rosemont Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
Glaucoma is one of the leading causes of blindness. Ginkgo biloba may be part of an effective treatment strategy for glaucoma because it has been shown to improve blood flow, it has antioxidant properties, it can relax smooth muscle, and it can protect neurons from damage. The goal of our study was to determine whether Ginkgo biloba would result in increased ocular blood flow which may protect against glaucoma damage.
Status | Completed |
Enrollment | 19 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - We focused this trial on vasospastic glaucoma patients because we believed that these would be the patients most likely to benefit from the ability of Ginkgo to improve blood flow. - Patients who had been identified from previous research as being vasospastic on the Transonic Laser Doppler Flowmeter (Transonic Systems Inc., Ithaca, NY) were contacted and asked if they would like to participate in the trial. - We recruited vasospastic patients with early or moderate primary open-angle glaucoma with a typical visual field defect with an abnormal Glaucoma Hemifield Test and a Mean Deviation worse than -2 decibels, and an optic nerve head showing retinal nerve fiber layer or neuroretinal rim loss characteristic of glaucoma. - There was no restriction for intraocular pressure at time of diagnosis although at the time of recruitment intraocular pressure had to be effectively controlled either by ocular hypertension therapy or by surgery. - If a patient had two eyes eligible, data from the right eye only was used. Exclusion Criteria: - those taking anticoagulant therapy, - those with blood disorders or diabetes, - women who were pregnant, planning to become pregnant, or who were breast-feeding, - patients with a history of seizures or who were currently taking anti-convulsant medication, and - those who could not return for 2 follow-up visits at 4 and 6 weeks. - those patients who are already taking Ginkgo were asked if they were willing to stop for 6 weeks before the study. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Maisonneuve-Rosemont Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Maisonneuve-Rosemont Hospital |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in optic nerve head blood flow in the rim region as measured with the Heidelberg Retinal Flowmeter | Change in optic nerve head blood flow in the rim region as measured with the Heidelberg Retinal Flowmeter | 4 weeks and 10 weeks | No |
Secondary | Change in retinal blood flow as measured by the Canon Laser Blood Flowmeter | Change in retinal blood flow as measured by the Canon Laser Blood Flowmeter | 4 weeks and 10 weeks | No |
Secondary | Change in ocular pulse amplitude as measured with the Pascal Dynamic Contour Tonometer | Change in ocular pulse amplitude as measured with the Pascal Dynamic Contour Tonometer | 4 weeks and 10 weeks | No |
Secondary | Change in peripheral vasospasm as measured during the cold provocation test using the Transonic Laser Doppler Flowmeter | Change in peripheral vasospasm as measured during the cold provocation test as measured using the Transonic Laser Doppler Flowmeter | 4 weeks and 10 weeks | No |
Secondary | Change in endothelin-1 levels as measured by an enzyme-linked immunosorbent assay kit | Change in endothelin-1 levels as measured by an enzyme-linked immunosorbent assay kit | 4 weeks and 10 weeks | No |
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