Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin (NCT04784234) | Clinical Trial Compass
TerminatedNot Applicable
Vision Preservation and Restoration Following a 6 Month Trial of GlaucoCetin
Stopped: company was bought and discontinued producing supplement
United States12 participantsStarted 2021-02-01
Plain-language 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.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age of 40 to 80 years
* Bilateral open angle glaucoma with reliable visual field defects (at least one eye with mean deviation (MD) between -4.00 to -10.00 decibels (dB) on Humphrey Visual Field 24-2.
* Group 1 (Peripheral): meets 1 hodapp-parrish-anderson (HPA) criteria for defect (3 contiguous points depressed on the pattern standard deviation (PSD) p \<5%, one of which is depressed at p \<1% level), and does not meet below paracentral criteria for Group 2.
* Group 2 (Central): at least 1 paracentral point repeatedly depressed at p\<1% on 24-2. Also meets the HAP criteria outlined above.
* Visual acuity 20/40 or better in each eye
* Intraocular Pressure (IOP) controlled at 2 measurements \>3 months
* Clear media
Exclusion Criteria:
* Known bleeding disorder
* History of epilepsy or on anti-seizure medication
* Uncontrolled hypertension or diabetes
* Uncontrolled IOP
* Eye pathology leading to inaccurate IOP measurement
* Visually significant retinal pathology affecting vision in past or active (such as diabetic retinopathy or age related macular degeneration)
* Non-glaucomatous optic neuropathy
* Visually significant cataract (worse then 2+ cataract, or what is determined visually clinically significant by physician)
* History of ocular trauma
* Selective laser trabeculoplasty or laser procedure within past 3 months
* Cataract surgery within past 3 months
* Incisional glaucoma surgery within 6 months
* Current use of nitroglycerin
* Current use…
What they're measuring
1
Visual Field Mean Deviation
Timeframe: 3 hour examinations during a 6 month period