Phase
Condition
Glaucoma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 studyassessments and visits.
Eyes with NTG will be enrolled.
Glaucoma severity will be graded using the WHO (World Health Organization)stagingsystem. NTG diagnosis will be based on the following:
Glaucomatous optic disc on slit-lamp biomicroscopy defined as cup-to-disc ratiogreater than 0.7, inter-eye asymmetry in cup-to-disc ration greater than 0.2 orneuroretinal rim notching, focal thinning, disc hemorrhage or vertical elongation ofoptic disc.
Glaucomatous visual field defects on at least three reliable visual field examinationsas measured by a glaucoma hemifield test (GHT) result outside normal limits and/or theappearance of at least three consecutive test points on the pattern deviation plotwith 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
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 withposterior 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).
Study Design
Study Description
Connect with a study center
New York Eye and Ear Infirmary of Mount Sinai
New York, New York 10003
United StatesActive - Recruiting
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