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Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin

Primary Open Angle Glaucoma Clinical Trial

Official title:
A Prospective Randomized Controlled Trial of GlaucoCetin vs Placebo in Glaucoma Patients With Visual Field Loss.

Clinical Trial Summary

This study is looking at changes in vision and visual function before and after a six month trial of a daily medical food called GlaucoCetin, formulated with ingredients to support and protect the optic nerve cells. Open angle glaucoma patients will be randomized to receive either a placebo or the medical food for 6 months. We hope to learn if this medical food can improve the vision of our glaucoma patients and to report the findings obtained to the general public.

Clinical Trial Description

The primary objective of this study is to evaluate the improvement in vision and visual function during a 6 month trial of GlaucoCetin versus placebo in patients with open angle glaucoma. The secondary objective is to evaluate change in quality of life, electrophysiologic response, and contrast sensitivity. Procedures involved during participation include review of medical/ocular history, best corrected visual acuity, multiple Humphrey visual field testing 24-2 and 10-2 , Octopus G-Top, pattern electroretinogram (PERG), ocular coherence tomography (OCT), ocular coherence tomography angiography (OCTA), intraocular pressure (IOP), contrast sensitivity testing (CSV-1000), corneal hysteresis, biomicroscopy, fundus exam, disc photos, and serum testing. To evaluate quality of life, included in testing is Compressed Assessment of Ability Related to Vision (CAARV). Responses to multiple surveys regarding vision related quality of life (GQL-15, Glaucoma Symptom Scale (GSS), National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)) and diet (NHANES Dietary Screener) will be captured. Number of daily steps will be monitored at 2 intervals during the study using pedometers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04784234
Study type Interventional
Source Wills Eye
Contact Natasha N Kolomeyer, MD
Phone 215-928-3123
Email nkolomeyer@willseye.org
Status Recruiting
Phase N/A
Start date February 1, 2021
Completion date December 31, 2023
View Details
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