About this trial
This study aims to determine whether a combination of vitamins (B6, B9, B12, and choline) can help protect the eyes of people with glaucoma and slow vision loss. The study will assess whether these vitamins support retinal cells and maintain or improve their function.
Adults aged 18 and older with primary open-angle glaucoma (including normal-tension glaucoma) or pseudoexfoliation glaucoma, and those with mild to moderate glaucoma, may be eligible. Participants must meet specific medical criteria and cannot take additional vitamin supplements during the study.
Participants will be randomly assigned to one of two groups: one group will take a daily vitamin supplement (B6, B9, B12, and choline) for one year, along with standard glaucoma care, while the other will continue standard care without extra vitamins. The vitamins used are well tolerated at selected doses, with possible mild side effects such as an upset stomach or tingling sensations. They will visit the clinic five times over 12 months (at the start, and at 3, 6, 9, and 12 months) for routine eye tests, including measuring eye pressure, checking vision and visual fields, taking scans of the eye's nerve layers (OCT), and completing an electroretinogram (ERG) to assess retinal function. Blood samples will also be collected.
If the vitamins are effective, this could provide an additional strategy alongside current eye pressure lowering treatments to reduce vision loss.
Eligibility criteria
Qualifiers
18 years or older at the time of inclusion
Diagnosis of Primary Open-Angle Glaucoma (POAG), Normal Tension-Glaucoma (NTG) or Pseudoexfoliation Glaucoma (PEXG) in one or both eyes diagnosticed by an ophthalmologist.
Best corrected Snellen VA of 0.3 or better in the study eye(s)
Two or more reliable VF tests with less than 15% false positives
Disqualifiers
Visual field damage worse than -16dB in the study eye(s)
Eye pressure greater than 35 mmHg in study eye(s) on either of two measurement occasions or a mean pressure of 30 mmHg over two occasions
Any disease affecting retinal function
Neurological or other non-glaucomatous conditions that may affect the visual field
Trial design
Treatments tested in this trial
- Vitamin B-mix
- Standard Care
Treatment groups
Sponsors and collaborators
Karolinska Institutet
Lead sponsor
St. Erik Eye Hospital
Collaborator