Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04784234
Brief 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.
Detailed 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:
NCT04784234
Study Brief:
Protocol Section:
NCT04784234