Effect of Vitamin Supplementation in Glaucoma Patients

The Effects of Vitamin Supplementation Containing L-Methylfolate (Ocufolin® Forte) on Retinal Venous Pressure and Homocysteine Plasma Levels in Patients With Glaucoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05080153

Enrollment

Registered

2021-10-15

Start date

2019-11-15

Completion date

2021-06-30

Last updated

2021-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Steady State Pattern Electroretinography, Elevated Retinal Venous Pressure, Glaucoma, Homocysteinemia

Keywords

glaucoma, homocysteine plasma levels, L-methylfolate, ophthalmodynamometry, retinal venous pressure (RVP), steady state pattern electroretinography

Brief summary

The impact of targeted vitamin supplementation on retinal venous pressure (RVP) and steady state pattern ERG (SSpERG) in patients with RVP 15mmHg or more above intra-ocular pressure (IOP) and serum homocystein 12µmol/l or more, with signs of progression in spite of adequate IOP control, as evidenced by SSpERG abnormality with or without structural progression or visual field progression,

Detailed description

Provided the inclusion criteria were met, RVP measurement was repeated, and a 1 capsule/day regimen of Ocufolin® forte was subsequently carried out for a duration of 3 months, after which repeat measurements of IOP, SSpERG, and RVP were performed, along with dilated fundoscopy. .

Interventions

DIETARY_SUPPLEMENTOcufolin forte

start of ocufolin forte 1 dd after RVP measurement, till 90 tablets are finished (3 months)

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* glaucoma and/or ocular vascular disease in at least on eye * abnormal SSpERG * RVP measured using an ophthalmodynamometer at least 15 mmHg higher than intra-ocular pressure (IOP), * fasting serum Hcy level \> 12 µmol/l * stable and well-controlled IOP (with or without IOP-lowering treatment)

Exclusion criteria

* starting other systemic or ocular medications with potential impacts on RVP within a month before entering the study or during the course of the study * starting or changing the dosage of other medications with potential impact on SSpERG within 3 months before entering the study or during the course of the study * non-adherence to the follow-up schedule * inability to perform a proper RVP measurement using ophthalmodynamometry.

Design outcomes

Primary

Measure	Time frame	Description
RVP effect	3 months	measurement of RVP lowering effect
SSpERG effect	3 months	measurement of improvement of SSpERG

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026