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NCT05080153 Clinical Trial

Effect of Vitamin Supplementation in Glaucoma Patients

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05080153
Other study ID # 151119-OcF
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 15, 2019
Est. completion date June 30, 2021

Study information
Verified date October 2021
Source Devogelaere Vision
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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,

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. .

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date June 30, 2021
Est. primary completion date October 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Ocufolin forte
start of ocufolin forte 1 dd after RVP measurement, till 90 tablets are finished (3 months)

Locations
Country Name City State
Belgium Devogelaere Vision Oudenburg

Sponsors (1)
Lead Sponsor Collaborator
Devogelaere Vision

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary RVP effect measurement of RVP lowering effect 3 months
Primary SSpERG effect measurement of improvement of SSpERG 3 months
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