Interventional Vitamin Mix Glaucoma Study (IVMGS) - A Prospective, Randomized, Two-Arm, Single-Center Study Protocol in Existing Glaucoma Patients.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Sweden
Karolinska institutet, The Division of Eye and vision.
NOT_YET_RECRUITING
Stockholm
St Eriks Ögonsjukhus
RECRUITING
Stockholm
Contact Information
Primary
Navid Golpour, Medical doctor
navid.golpour@ki.se
+46737085148
Backup
James Tribble, Associate Professor
james.tribble@ki.se
Time Frame
Start Date: 2025-03-31
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Intervention
Participants in this arm receive both the Vitamin B-mix supplement and standard glaucoma care.
Active_comparator: Controls
Participants in this arm receive standard glaucoma care only.
Sponsors
Leads: Karolinska Institutet
Collaborators: St. Erik Eye Hospital

This content was sourced from clinicaltrials.gov