Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTG
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|ClinicalTrials.gov Identifier: NCT03761992|
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : December 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Normal Tension Glaucoma||Dietary Supplement: Gingko Baloba Other: Placebo||Not Applicable|
GBE has been reported to improve blood flow to the brain, eye, and extremeties(hands, feet,etc.). .As with most supplements, GBE is neither regulated nor FDA approved.
A technique called Optical Coherence Tomography Angiography (OCTA),will be used to measure the small blood vessels at the back of the eye, the macula (the area of sharpest vision), and the optic disc (the point at which the nerve fibers from the retina enter to form the optic nerve, which transmits visual impulses to the brain). This technique uses a camera, capable of imaging the smallest vessels, so that their density (number) can be calculated by a computer. This is being done to determine if there is disease causing increasing loss of these vessels. The imaging is done by a widely used camera which does not contact the eye. It simply uses visible light to measure the amount of blood vessels present in a determined area in the back of the eye. Blood flow at the 4th finger nailfold (nailfold capillaroscopy; NFC) is a standard technique, especially in rheumatology, performed by using a commercially available light microscope which glides over the base of the fingernail and can image the tiny capillaries in the nailfold. These images are recorded as videos from which the blood flow can be analyzed by freely available software for the purpose of quantitative measurements (amount of blood flow and blood flow velocity).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Gingko baloba extract (GBE) versus placebo|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Neither the patient nor the investigator will know which treatment that the patient is receiving.|
|Official Title:||Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in Normaltension Glaucoma by Ocular Coherence Tomography Angiography and Nailfold Capillaroscopy|
|Actual Study Start Date :||November 19, 2018|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
Active Comparator: Gingko Biloba Extract
Gingko Biloba Extract 240 mg.
Dietary Supplement: Gingko Baloba
Other Name: 240mg. Gingko Biloba
Placebo Comparator: Placebo
- Primary Outcome - Measure of Blood Vessel by Optical Cohrence Tomography Angiography (OCTA) [ Time Frame: 4 weeks ]The investigators plan to evaluate the density of the small blood vessels at the back of the eye. This will be measured by a OCTA. A camera capable of imaging the smallest vessels so that their density (number) can be calculated by a computer, the purpose being to determine if there is disease causing progressive loss of these vessels.
- Secondary Outcome - Measure of Blood Flow and Velocity by Nailfold Capillaroscopy (NFC) [ Time Frame: 4 weeks ]Measuring blood flow at the 4th finger nailfold by NFC is a standard technique, especially in rheumatology, in which a commercially available light microscope glides over the base of the fingernail to image the tiny capillaries in the nailfold. These images are recorded as videos from which the blood flow can be analyzed quantitatively by freely available software to measure blood flow and velocity.
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): NCT03761992
|Contact: Robert Ritch, MDemail@example.com|
|Contact: Luis Silva MD, MDfirstname.lastname@example.org|
|United States, New York|
|New York Eye and Ear Infirmary of Mount Sinai||Recruiting|
|New York, New York, United States, 10003|
|Contact: Robert Ritch, MD 212-477-7540 email@example.com|
|Contact: Luis Silva, MD 212-477-7540 firstname.lastname@example.org|
|Principal Investigator:||Robert Ritch, MD||New York Eye and Ear Infirmary of mount Sinai|