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Effect of Vitamin Supplementation in Glaucoma Patients

NCT ID: NCT05080153

Last Updated: 2021-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-15

Study Completion Date

2021-06-30

Brief Summary

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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

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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. .

Conditions

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Glaucoma Homocysteinemia Elevated Retinal Venous Pressure Abnormal Steady State Pattern Electroretinography

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ocufolin forte

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Devogelaere Vision

OTHER

Sponsor Role lead

Responsible Party

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Thibaut Devogelaere

Dr T Devogelaere, MD, FEBO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thibaut Devogelaere, MD, FEBO

Role: PRINCIPAL_INVESTIGATOR

Vision Devogelaere

Locations

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Devogelaere Vision

Oudenburg, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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151119-OcF

Identifier Type: -

Identifier Source: org_study_id