The Effect of Vitamin B3 Supplementation in Glaucoma

Phase 4

Completed

• Conditions: Glaucoma; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12617000809336
• Lead Sponsor: Centre for Eye Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-02
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Diagnosis of primary open angle glaucoma by an ophthalmologist
- Recent (last 6 months), reliable visual field with mean defect equal to or better than -6 dB

Exclusion Criteria

- those who are currently or intending to be pregnant/breastfeeding during the study
- those unwilling to abstain from other vitamin B supplements during the study period
- history of severe allergies or allergic reaction to nicotinamide or niacin
- those diagnosed with cancer in the last 5 years (except treated basal or squamous cell carcinoma)
- those with a history of liver disease
- those who cannot commit to the follow-up visits which occur at 6-weekly intervals over 24 weeks
- those who cannot provide informed consent
- eyes with a history of intraocular surgery in the past 6 months (uncomplicated cataract surgery within the last 3 months)
- systemic/ocular disease that are known to affect retinal function (e.g. age-related macular degeneration, demyelinating diseases, diabetic retinopathy)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short-term changes in retinal function after intervention, specifically visual field sensitivity assessed using perimetry (visual field machine)[12 weeks after commencement of intervention];Short-term changes in retinal function after intervention, specifically changes to the photopic (light-adapted) electroretinogram (ERG). As nicotinamide leads to NAD+ repletion, which can drive energy repletion in the cells of the retina, the ERG can be affected in different ways. Specific parameters include amplitude and timing changes to the a-wave (photoreceptor), b-wave (bipolar cell) and photopic negative response (PhNR, retinal ganglion cell). [12 weeks after commencement of intervention]