Status:
RECRUITING
Vitamin Mix (B6, B9, B12, And Choline) For Glaucoma Patients
Lead Sponsor:
Karolinska Institutet
Collaborating Sponsors:
St. Erik Eye Hospital
Conditions:
Open-angle Glaucoma
Pseudoexfoliation Glaucoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 vi...
Eligibility Criteria
Inclusion
- Eligibility 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
- 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
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06885827
Start Date
March 31 2025
End Date
March 31 2027
Last Update
April 29 2025
Active Locations (2)
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1
St Eriks Ögonsjukhus
Stockholm, Stockholm County, Sweden, 11251
2
Karolinska institutet, The Division of Eye and vision.
Stockholm, Stockholm County, Sweden, 14186