Effect of Vitamin Supplementation in Glaucoma Patients

Completed

• Conditions: Glaucoma; Abnormal Steady State Pattern Electroretinography; Elevated Retinal Venous Pressure; Homocysteinemia

• Registration Number: NCT05080153
• Lead Sponsor: Devogelaere Vision

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. .

Study Timeline

• Study Start: 2019-11-15
• Primary Completion: 2020-10-31
• Study Completion: 2021-06-30
• Status Verified: 2021-10
• Study First Submitted: 2021-10-05
• Study First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RVP effect	3 months	measurement of RVP lowering effect
SSpERG effect	3 months	measurement of improvement of SSpERG

Trial Locations

Locations (1)

Devogelaere Vision; 🇧🇪 Oudenburg, Belgium