Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTG

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2020-12-31

Brief Summary

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The purpose of this study is to evaluate the effect of Ginkgo biloba extract (GBE) on the number of blood vessels in the back of the eye as well as the amount of blood flow at the nailfold(where the fingernail meets the skin) of the 4th finger in the hand.This finger, along with the 5th finger, has the most transparent skin, which makes imaging a little easier. GBE is an over-the-counter pill, made from a natural powder taken from the Gingko (Maidenhair) tree, that is widely used. 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).

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Detailed Description

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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).

Conditions

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Normal Tension Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Gingko baloba extract (GBE) versus placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Neither the patient nor the investigator will know which treatment that the patient is receiving.

Study Groups

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Gingko Biloba Extract

Gingko Biloba Extract 240 mg.

Group Type ACTIVE_COMPARATOR

Gingko Baloba

Intervention Type DIETARY_SUPPLEMENT

Tablets

Placebo

Placebo Pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Tablets

Interventions

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Gingko Baloba

Tablets

Intervention Type DIETARY_SUPPLEMENT

Placebo

Tablets

Intervention Type OTHER

Other Intervention Names

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240mg. Gingko Biloba

Eligibility Criteria

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Inclusion Criteria

Male or female of any race, at least 18 years of age

* Has provided verbal and written informed consent.
* Able and willing to follow instructions, including participation in all study assessments and visits.
* Eyes with NTG will be enrolled.
* Glaucoma severity will be graded using the WHO (World Health Organization)staging system.

NTG diagnosis will be based on the following:

1. Glaucomatous optic disc on slit-lamp biomicroscopy defined as cup-to-disc ratio greater than 0.7, inter-eye asymmetry in cup-to-disc ration greater than 0.2 or neuroretinal rim notching, focal thinning, disc hemorrhage or vertical elongation of optic disc.
2. Glaucomatous visual field defects on at least three reliable visual field examinations as measured by a glaucoma hemifield test (GHT) result outside normal limits and/or the appearance of at least three consecutive test points on the pattern deviation plot with p\<1% and at least one at p\<0.05%, not including points on the edge of the field.
3. NTG will be defined as those subjects with a history of untreated peak IOP ≤21 mmHg.

* Both eyes will be enrolled

Exclusion Criteria

* Best-corrected visual acuity less than 20/40
* Age younger than 18 years or older than 85 years
* Refractive error greater than +3.00 diopters (D) or less than -7.00 diopters (D)
* Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation
* Any other diseases that may cause visual field loss or optic disc abnormalities
* Inability to perform reliably on automated visual field testing.
* Subjects taking any GBE product will be washed out for 2 weeks prior to enrollment.
* Diabetes.
* Seizure disorder.
* Taking any drugs that may interact with GBE (as listed).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No