Evidence map›Paper›PMID 41084053›Full record

ArticleTrials2025

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, Jonas Svensson, Rune L Brautaset, James R Tribble, Pete A Williams

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06885827 (Interventional Vitamin Mix Glaucoma Study), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06885827 narecruitingnot on this map

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

TypeinterventionalSponsorKarolinska InstitutetRan2025 to 2027Enrolled80ConditionsOpen-angle Glaucoma, Pseudoexfoliation GlaucomaArmsVitamin B-mix, Standard Care
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Navid GolpourDepartment of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden.
Flora HuiCentre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.
Maria NilssonDepartment of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden.
Jonas SvenssonDepartment of Clinical Neuroscience, Karolinska Institutet and Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden.
Rune L Brautaset *Department of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. rune.brautaset@ki.se.
James R Tribble *Department of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. james.tribble@ki.se.
Pete A Williams *Department of Clinical Neuroscience, Division of Eye and Vision, St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. pete.williams@ki.se.ORCID http://orcid.org/0000-0001-6194-8397

Funding

Vetenskapsrådet 2022-00799
6 · The paper itself

Abstract

backgroundGlaucoma is a leading cause of irreversible blindness, characterized by progressive degeneration of retinal ganglion cells. Current treatments primarily lower intraocular pressure but do not directly provide neuroprotection. Preclinical studies from our group have identified dysfunction in one-carbon metabolism as a contributor to glaucomatous neurodegeneration in rodent models. The Interventional Vitamin Mix Glaucoma Study will evaluate whether 12 months of supplementation with key one-carbon metabolism cofactors and precursors (vitamins B

methodsThe Interventional Vitamin Mix Glaucoma Study is a Phase 2a, open-label, randomized, two-arm clinical trial. Participants will be assigned in a one-to-one ratio to receive either daily one-carbon metabolism supplementation plus standard care or standard care alone. The study will enroll 80 patients with primary open-angle glaucoma, normal tension glaucoma, or pseudoexfoliation glaucoma, each with mild-to-moderate visual field loss in at least one eye. Recruitment will take place from March 2025 to March 2026 at St. Erik Eye Hospital, Karolinska Institutet, Stockholm, Sweden. The primary outcome is change in the photopic negative response measured by full-field electroretinography. Secondary outcomes include changes in visual field parameters, retinal nerve fiber layer thickness, and ganglion cell-inner plexiform layer thickness. Exploratory outcomes will include changes in blood-based metabolomic and DNA methylation profiles. DISCUSSION: One-carbon metabolism-based supplementation has been shown to reduce retinal ganglion cell loss in rodent models of glaucoma. This trial will investigate whether such supplementation improves retinal function and confers neuroprotection in patients with glaucoma. The use of full-field electroretinography as the primary outcome aims to detect early functional improvements in the retina. If successful, this approach could support a low-cost, widely available neuroprotective strategy to be used alongside existing intraocular pressure-lowering therapies.

trial registrationThis trial is registered at ClinicalTrials.gov (NCT06885827), first posted on 20 March 2025.

Indexed as

Dietary SupplementsGlaucomaVitaminsClinical Trials, Phase II as TopicElectroretinographyFemaleHumansIntraocular PressureMaleNeuroprotective AgentsProspective StudiesRandomized Controlled Trials as TopicRetinal Ganglion CellsTreatment OutcomeVisual FieldsNeuroprotective AgentsVitaminsB12B9ColineElectroretinographyGlaucomaNeuroprotectionOne-carbon metabolismPhotopic negative responseProtocolRandomized controlled trialVitamins B6

Identifiers

PMID41084053
PMCPMC12516856

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.