Effect of Vitamin Supplementation in Glaucoma Patients

Brief Title

Effect of Vitamin Supplementation in Glaucoma Patients

Official Title

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

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 Type


Primary Outcome

RVP effect




Ocufolin forte


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Dietary Supplement

Estimated Enrollment


Start Date

November 15, 2019

Completion Date

June 30, 2021

Primary Completion Date

October 31, 2020

Eligibility Criteria

        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.




N/A - N/A

Accepts Healthy Volunteers



Thibaut Devogelaere, MD, FEBO, , 

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Devogelaere Vision

Study Sponsor

Thibaut Devogelaere, MD, FEBO, Principal Investigator, Vision Devogelaere

Verification Date

October 2021