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

Observational


Primary Outcome

RVP effect


Condition

Glaucoma

Intervention

Ocufolin forte


Publications

* 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

26

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Thibaut Devogelaere, MD, FEBO, , 

Location Countries

Belgium

Location Countries

Belgium

Administrative Informations


NCT ID

NCT05080153

Organization ID

151119-OcF


Responsible Party

Principal Investigator

Study Sponsor

Devogelaere Vision


Study Sponsor

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


Verification Date

October 2021