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

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,

Study Overview

• Status: Completed
• Conditions: Glaucoma; Homocysteinemia; Elevated Retinal Venous Pressure; Abnormal Steady State Pattern Electroretinography
• Intervention / Treatment: Dietary supplement: Ocufolin forte

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. .

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

• Belgium
  • Oudenburg, Belgium, 8460
    • Devogelaere Vision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with glaucoma and/or ocular vascular disease with signs of progression in spite of well controlled IOP and elevated RVP, with fasting serum Hcy level > 12 µmol/l

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Devogelaere Vision
• Investigators: Principal Investigator: Thibaut Devogelaere, MD, FEBO, Vision Devogelaere

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): October 31, 2020
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: October 5, 2021
• First Submitted That Met QC Criteria: October 5, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: glaucoma; L-methylfolate; homocysteine plasma levels; ophthalmodynamometry; retinal venous pressure (RVP); steady state pattern electroretinography
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 151119-OcF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No