Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784234
Status:
UNKNOWN
Last Update Posted:
2022-07-05
First Post:
2021-03-02
Brief Title:
Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin
Sponsor:
Wills Eye
Organization:
Wills Eye
Study Overview
Official Title:
A Prospective Randomized Controlled Trial of GlaucoCetin vs Placebo in Glaucoma Patients With Visual Field Loss
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 medicalocular 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
Procedures involved during participation include review of medicalocular 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None