Glaucoma, Open-Angle, Visual Field Defect, Peripheral
Conditions
Keywords
Perimetry, Vitamins, Glaucoma, Supplements, Vitamin B3, Nicotinamide
Brief summary
This study seeks to test whether these over-the-counter nutritional supplements have an impact on patients' performance during visual field testing.
Detailed description
Glaucoma is the leading cause of irreversible blindness worldwide. The most important test to detect progression is visual field testing. Visual field testing is the reference standard to measure visual function in glaucoma. It is called called standard automated perimetry (SAP). However, this test is very subjective, often unreliable, and variable. One of the main causes of unreliable tests is the lack of attentiveness or concentration during the test. Previous studies have shown that listening to Mozart or taking vitamin B12 can improve the reliability of this test. Recent studies have suggested that over-the-counter medications such as nicotinamide (vitamin B3) and pyruvate can also improve the performance during this test. This can ultimately reduce costs due to repeated testing and increase doctor's certainty when analyzing the results of this test.
Interventions
DIETARY_SUPPLEMENTVitamin B3
3 tablets of 1000 mg each will be administered orally.
DIETARY_SUPPLEMENTPyruvate
2 tablets of 1500 mg each will be administered orally.
DIETARY_SUPPLEMENTPlacebo
Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Confirmed diagnosis of primary open-angle glaucoma; * Visual field loss on 24-2 standard automated perimetry (SAP) worse than -3 decibels (dB) and better than -12 dB in both eyes; * Best corrected visual acuity better than 20/40 in both eyes; * Prior experience with 24-2 visual fields (at least 3 tests done in the past 3 years).
Exclusion criteria
* Significant cataract or media opacity; * Diagnosis of dementia, Alzheimer's, and other neurological diseases; * Current use or use in the past 1 month of nutritional supplements; * Inability to take or intolerance to nicotinamide and/or pyruvate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-2 visual field test | Up to 20 weeks | Changes in 24-2 visual field results based upon point-wise and global metrics before and after intervention, and between treatment and placebo groups will be compared. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Montreal Cognitive Assessment (MoCA) scores | Up to 20 weeks | Montreal Cognitive Assessment (MoCA) score before and after intervention and correlate these changes with those seen on visual field tests will be compared. The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that assesses different types of cognitive abilities. Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal. |
Countries
United States
Outcome results
None listed