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OpenTrials
Completed

NCT Number: NCT05080153

Effect of Vitamin Supplementation in Glaucoma Patients

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,

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Key information

Conditions

Glaucoma Abnormal Steady State Pattern Electroretinography Elevated Retinal Venous Pressure Eye Diseases Homocysteinemia Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Devogelaere Vision

Oudenburg, 8460, Belgium

About this study

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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ocufolin forte

Dietary Supplement

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

Primary outcomes

  1. RVP effect

    Time frame: 3 months

    measurement of RVP lowering effect

  2. SSpERG effect

    Time frame: 3 months

    measurement of improvement of SSpERG

Sponsors and collaborators

Lead sponsor

Devogelaere Vision

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Oct 15, 2021
Registry last updated
Oct 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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