Status:
UNKNOWN
Measurement of the Effect of Gingko Biloba Extract on Ocular and Nailfold Blood-flow in NTG
Lead Sponsor:
Robert Ritch, MD, LLC.
Conditions:
Normal Tension Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 f...
Detailed Description
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 Cohe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03761992
Start Date
November 19 2018
End Date
December 1 2020
Last Update
March 17 2020
Active Locations (1)
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1
New York Eye and Ear Infirmary of Mount Sinai
New York, New York, United States, 10003