Effect of Vitamin Supplementation in Glaucoma Patients

Sponsor

Devogelaere Vision (Other)

Overall Status

Completed

CT.gov ID

NCT05080153

Collaborator

(none)

Enrollment

Location

19.5

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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,

Condition or Disease	Intervention/Treatment	Phase
Glaucoma Homocysteinemia Elevated Retinal Venous Pressure Abnormal Steady State Pattern Electroretinography	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 Design

Study Type:

Observational

Actual Enrollment :

26 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 15, 2019

Actual Primary Completion Date :

Oct 31, 2020

Actual Study Completion Date :

Jun 30, 2021

Outcome Measures

Primary Outcome Measures

RVP effect [3 months]
measurement of RVP lowering effect
SSpERG effect [3 months]
measurement of improvement of SSpERG

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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.