Vitamin mix for glaucoma patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.