Evidence map›Paper›PMID 41461224›Full record

Trial reportOphthalmology. Glaucoma

Nicotinamide and Pyruvate in Open-Angle Glaucoma: A Randomized Controlled Trial on Neuroprotection-Design and Methodology.

Aakriti Garg Shukla, Emmanouil Tsamis, Carlos Gustavo De Moraes, Simon W John, Donald C Hood, Jeffrey L Goldberg, Lisa A Hark, Marzhan Atakulova, Yujia Wang, David S Greenfield and 2 more

Abstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Ophthalmology. Glaucoma. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Review
  3. 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

12 authors.

Aakriti Garg ShuklaDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York. Electronic address: ag2965@cumc.columbia.edu.
Emmanouil TsamisDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.
Carlos Gustavo De MoraesDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.
Simon W JohnDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.
Donald C HoodDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.
Jeffrey L GoldbergSpencer Center for Vision Research, Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California.
Lisa A HarkDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.
Marzhan AtakulovaDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.
Yujia WangDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.
David S GreenfieldBascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.
George A CioffiDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.
Jeffrey M LiebmannDepartment of Ophthalmology, Columbia University Vagelos College of Physicians and Surgeons, New York, New York; Bernard and Shirlee Glaucoma Research Laboratory, Columbia University Irving Medical Center, New York, New York.

Funding

Stanford Vision Research CoreP30EY026877 · NEI · STANFORD UNIVERSITY · PI Jeffrey L Goldberg · 2017 to 2026
$8.0M
Development, validation and assessment of an automated, topographic structure-function approach to the detection of glaucoma and its progressionR00EY032182 · NEI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI Emmanouil Tsamis · 2024 to 2026
$745k
NEI NIH HHS P30 EY026877NEI NIH HHS R00 EY032182
6 · The paper itself

Abstract

purposeThe Nicotinamide and Pyruvate in Open-Angle Glaucoma Trial aims to establish whether nicotinamide and pyruvate dietary supplementation provides neuroprotection in eyes with treated open-angle glaucoma (OAG).

designA prospective, two-site, 21-month, placebo-controlled, double-masked, phase III randomized clinical trial.

participantsOpen-angle glaucoma patients recruited at Columbia University Irving Medical Center and Stanford University between March 1, 2023, and August 30, 2025.

interventionStudy participants were randomized in a 1:1 ratio to either active product (3 g/day of nicotinamide and 1 g/day of calcium pyruvate) or placebo. Standard-of-care intraocular pressure-lowering treatment is continued throughout the study and can be modified at the discretion of the treating physician.

main outcome measuresThe primary outcome measure is a composite of functional change based on automated perimetry of the central 10° of the visual field and/or structural change based on spectral-domain OCT. Periodic blood collection allows for evaluation of intervention-related metabolomics, transcriptomics, and proteomics, and measurement of serum levels of nicotinamide and pyruvate. Secondary outcomes include the evaluation of the tolerability and safety of nicotinamide and pyruvate in OAG and the identification of factors that predispose to greater responsiveness to metabolic neuroprotective therapies in OAG. An intention-to-treat analysis will be performed at the conclusion of the trial.

conclusionsThis novel trial design may deliver valuable data on the neuroprotective potential of nicotinamide and pyruvate supplementation in glaucoma and improve our understanding of optimal study design for longitudinal randomized clinical trials focused on glaucoma neuroprotection. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Indexed as

Dietary SupplementsGlaucoma, Open-AngleIntraocular PressureNeuroprotectionNiacinamidePyruvic AcidVisual FieldsAgedDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedNeuroprotective AgentsProspective StudiesNeuroprotective AgentsNiacinamidePyruvic AcidGlaucomaNeuroprotectionNeurorecoveryNicotinamidePyruvate

Identifiers

PMID41461224
PMCPMC13003422

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.