Interventional Vitamin Mix Glaucoma Study (IVMGS): study protocol for a prospective, randomized, two-arm, single-center trial in existing glaucoma patients.
Navid Golpour, Flora Hui, Maria Nilsson...
https://pubmed.ncbi.nlm.nih.gov/41084053Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06885827
Interventional Vitamin Mix Glaucoma Study (IVMGS) - A Prospective, Randomized, Two-Arm Study in Glaucoma Patients
Led by Karolinska Institutet · Updated on 2025-04-29
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
S
St. Erik Eye Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate whether a combination of vitamins B6, B9, B12, and choline can help protect the eyes and slow vision loss in adults with glaucoma, including primary open-angle glaucoma, normal-tension glaucoma, and pseudoexfoliation glaucoma. The study focuses on whether these vitamins support retinal cells and maintain or improve their function alongside standard glaucoma care. Participants will be randomly assigned to one of two groups. One group will take a daily vitamin B-mix supplement along with their usual glaucoma treatment for one year, while the other group will continue with standard care without extra vitamins. The vitamin doses are selected to be well tolerated, with possible mild side effects such as upset stomach or tingling sensations. The study involves five clinic visits over 12 months, with eye tests, scans of the nerve layers, electroretinograms to assess retinal function, and blood sample collection. Participants will have routine eye pressure checks, vision and visual field tests, and scans at the start and every three months until the end of the study. Researchers will measure changes in retinal function using electroretinography, retinal structure, visual field indices, eye pressure, visual acuity, and blood biomarkers. The study includes monitoring for safety and adherence throughout the 12 months, providing a comprehensive evaluation of the vitamin mix as a possible additional approach to reduce vision loss in glaucoma patients.
CONDITIONS
Brief Title
Vitamin Mix (B6, B9, B12, And Choline) For Glaucoma Patients
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of inclusion
- Diagnosis of Primary Open-Angle Glaucoma, Normal Tension-Glaucoma, or Pseudoexfoliation Glaucoma diagnosed by an ophthalmologist
- Best corrected Snellen visual acuity of 0.3 or better in the study eye(s)
- Two or more reliable visual field tests with less than 15% false positives
You will not qualify if you...
- Visual field damage worse than -16dB in the study eye(s)
- Eye pressure greater than 35 mmHg on two occasions or mean pressure of 30 mmHg over two occasions in the study eye(s)
- Any disease affecting retinal function
- Neurological or other non-glaucomatous conditions affecting the visual field
- Inability to perform visual field examination
- Unwillingness to stop multivitamins or B vitamin supplements
- Known allergy or intolerance to B-vitamins
- Previous eye surgery except uncomplicated cataract surgery
- Pregnant or breastfeeding women
- Women of childbearing potential not using reliable contraception
- Any disease or condition preventing long-term follow-up
- Cancer diagnosis within last 5 years except treated squamous cell carcinoma
- History of liver disease or stomach ulcers
- Inability to understand and speak Swedish or English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants receive either daily oral Vitamin B-mix supplementation alongside standard glaucoma care or standard care alone.
Visits at baseline, 3 months, and 12 months
Trial Site Locations
Total: 2 locations
1
St Eriks Ögonsjukhus
Stockholm, Stockholm County, Sweden, 11251
Actively Recruiting
2
Karolinska institutet, The Division of Eye and vision.
Stockholm, Stockholm County, Sweden, 14186
Not Yet Recruiting
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Research Team
N
Navid Golpour, Medical doctor
J
James Tribble, Associate Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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