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

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Normal Tension Glaucoma

In brief

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).

Key facts

Study ID

NCT03761992

Run by

Robert Ritch, MD, LLC.

People needed

40

Starts

2018-11-19

Expected to finish

2020-12-01

Last updated by the study team

2020-03-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.
• 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.
• NTG will be defined as those subjects with a history of untreated peak IOP ≤21 mmHg.
• Both eyes will be enrolled

You may not qualify if…

• 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).

Where it is running

• New York Eye and Ear Infirmary of Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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