Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue

• Sponsor: State University of New York College of Optometry (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04448535
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35
• Patients Per Site Per Month: 1.7

Study Details

Study Description

Brief Summary

The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on retinal and choroidal ocular tissue.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Dietary Supplement: Gingko Biloba	N/A

Detailed Description

The study objectives are to:

1. assess the changes from pre- to post- oral supplementation on retinal and choroidal thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal function

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue
• Actual Study Start Date: Jan 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Gingko Biloba oral intake of gingko biloba for 4 weeks	Dietary Supplement: Gingko Biloba; oral intake of Gingko Biloba, 240mg/day for 4 weeks

Outcome Measures

Primary Outcome Measures

1. ocular blood flow [4 weeks]

   ocular blood flow measured with doppler ultrasound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Aged between 20 - 55 years, inclusive

• Good general and ocular health

• Corrected visual acuity of 20/40 or better

• No gingko biloba supplementation within the last 3 months

Exclusion Criteria:

• All significant ocular and any systemic disorders considered likely to affect the systemic or ocular vasculature

• History of ocular surgery, including refractive surgery

• Use of ocular medications

• Conditions where ginkgo supplementation is contraindicated

• Any eye or systemic disease that affect vision or refractive error

• Current smokers

• Subjects who are pregnant, breastfeeding, or planning conception

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SUNY College of Optometry	New York	New York	United States	10036

Sponsors and Collaborators

• State University of New York College of Optometry

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexandra Benavente, Associate Clinical Professor, State University of New York College of Optometry
• ClinicalTrials.gov Identifier: NCT04448535
• Other Study ID Numbers: 1619383-1
• First Posted: Jun 26, 2020
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 18, 2021