Effect of Vitamin Supplementation in Glaucoma Patients

NCT05080153 | Completed

• 1 other identifier: 151119-OcF
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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,

Conditions

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

Keywords

glaucoma; homocysteine plasma levels; L-methylfolate; ophthalmodynamometry; retinal venous pressure (RVP); steady state pattern electroretinography

Outcome Measures

Primary Outcomes (2)

• RVP effect

  measurement of RVP lowering effect

  3 months

• SSpERG effect

  measurement of improvement of SSpERG

  3 months

Interventions

Ocufolin forte DIETARY_SUPPLEMENT

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Devogelaere Vision: lead

Study Sites (1)

Devogelaere Vision

Oudenburg, 8460, Belgium

Location

MeSH Terms

Conditions

Glaucoma; Homocysteinemia

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Thibaut Devogelaere, MD, FEBO

  Vision Devogelaere

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr T Devogelaere, MD, FEBO

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 15, 2021
• Study Start: November 15, 2019
• Primary Completion: October 31, 2020
• Study Completion: June 30, 2021
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)