Vitamin mix for glaucoma patients
Interventional Vitamin Mix Glaucoma Study (IVMGS) - A Prospective, Randomized, Two-Arm, Single-Center Study Protocol in Existing Glaucoma Patients.
This study is testing if a mix of certain vitamins can help protect the eyes and slow vision loss in people with glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Karolinska Institutet Academic / other |
| Locations | 2 sites (Stockholm, Stockholm County and 1 other locations) |
| Trial ID | NCT06885827 on ClinicalTrials.gov |
What this trial studies
This study investigates whether a combination of vitamins B6, B9, B12, and choline can protect the eyes of individuals with glaucoma and slow down vision loss. Participants aged 18 and older with primary open-angle glaucoma or pseudoexfoliation glaucoma will be randomly assigned to receive either the vitamin supplement or standard glaucoma care for one year. The study aims to assess the vitamins' potential to support retinal cell function and overall eye health. Participants will attend five clinic visits throughout the study period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with primary open-angle glaucoma or pseudoexfoliation glaucoma.
Not a fit: Patients with severe visual field damage or other conditions affecting retinal function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help preserve vision and improve the quality of life for glaucoma patients.
How similar studies have performed: While the use of vitamin supplementation in glaucoma is a novel approach, similar studies have shown potential benefits of nutritional support in eye health.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility Criteria Inclusion Criteria: Patients with the following characteristics will be eligible for inclusion in the trial: * 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 Exclusion Criteria: Patients who meet any of the following criteria will be excluded from participation in the study: * 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 * Inability to perform visual field examination * Unwillingness to stop any intake of multivitamins or B vitamin substances * Known allergy or intolerance to B-vitamins * Previous eye surgery, except for uncomplicated cataract surgery * Pregnant or breastfeeding women * Women of childbearing potential who do not use reliable contraception * Any disease or condition likely to prevent long-term follow-up * Cancer diagnosis within the last 5 years (except treated squamous cell carcinoma) * History of liver disease or stomach ulcers * Inability to understand and speak Swedish or English
Where this trial is running
Stockholm, Stockholm County and 1 other locations
- St Eriks Ögonsjukhus — Stockholm, Stockholm County, Sweden (Recruiting)
- Karolinska institutet, The Division of Eye and vision. — Stockholm, Stockholm County, Sweden (Not_yet_recruiting)
Study contacts
- Principal investigator: Rune Brautaset, Professor of Optometry — Karolinska Institutet
- Study coordinator: Navid Golpour, Medical doctor
- Email: navid.golpour@ki.se
- Phone: +46737085148
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.