Data

VBIGS 2023 trial participants with glaucoma 18+

The University of Melbourne

Dataset description

Clinical and ocular health data measured 4-monthly over 2 years in 424 adult (18+) participants with treated glaucoma at time of enrolment.
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Related Datasets

Subjects

Ophthalmology |

Related Study

The Vitamin B3 in Glaucoma Study (VBIGS)

Brief Summary

This study builds upon our world-first clinical trial of nicotinamide in glaucoma (ACTRN12617000809336) demonstrating the potential protective role of vitamin B3 (nicotinamide) supplements in people with glaucoma. Glaucoma causes progressive loss of nerve tissue in the eye, and irreversible vision loss. This study investigates the effect of taking nicotinamide supplements over 2 years on the eye’s structure and function compared to placebo. The primary aim of this study is to determine whether nicotinamide supplements in participants with glaucoma leads to reduced rate of progression in visual function measured using visual fields over 2 years. Participants diagnosed and treated for glaucoma will be invited to undertake the study. They will be randomly assigned to take nicotinamide or placebo daily for 24 months. Clinical tests including visual fields and imaging of the eye are performed at baseline, and every 4 months post-intervention.

Conditions

Condition Codes

Intervention Code

Inclusion Criteria

  • • Adults with definitive, treated primary open angle glaucoma (POAG), normal tension glaucoma (NTG) or pseudoexfoliative glaucoma (PXFG) in both eyes • Best-corrected visual acuity of at least 6/18 in each eye • Severity of visual field (VF) loss, mean deviation (MD) between -3 and -18 dB. This range includes people with moderate disease which optimises detection of progression. • Patients must have prior 2-3 x 24-2 VF tests in the past which meet VF reliability criteria. • Previous selective laser trabeculoplasty is acceptable (IOP-lowering laser treatment) if more than 3 months prior, and normal liver function tests. • Those taking nicotinamide (NAM) already will undergo a 1-month washout period before commencing the study.

Study Type

  • Interventional

Ethics Approval

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

De-identified participant data underlying published results

When will data be available?

Data will be available following publication. No end date

Available to whom?

Researchers who provide a methodologically sound proposal The trial database may by uploaded to the Health Studies National Data Asset program (HeSANDA) following completion

Available for what types of analyses?

To achieve the aims in the proposal