GlaucomaNCT05080153
Effect of Vitamin Supplementation in Glaucoma Patients
An observational study of Glaucoma and Homocysteinemia, run by Devogelaere Vision at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Homocysteinemia, Elevated Retinal Venous Pressure
- What is being tested?
- Ocufolin forte
- Type of treatment
- Pill or oral medicine
- How many people
- 26 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2019to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Vitamin Supplementation Containing L-Methylfolate (Ocufolin® Forte) on Retinal Venous Pressure and Homocysteine Plasma Levels in Patients With Glaucoma
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,
Read the 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. .
- Conditions
- Glaucoma, Homocysteinemia, Elevated Retinal Venous Pressure, Abnormal Steady State Pattern Electroretinography
- Being tested
- Ocufolin forte
- Keywords
- glaucoma, homocysteine plasma levels, L-methylfolate, ophthalmodynamometry, retinal venous pressure (RVP), steady state pattern electroretinography
- Medical subject headings
- Glaucoma, Homocysteinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocufolin forteDietary supplement
start of ocufolin forte 1 dd after RVP measurement, till 90 tablets are finished (3 months)
What is being measured
The primary outcome is the main question the study is designed to answer.
RVP effect
measurement of RVP lowering effect
Measured: 3 months
SSpERG effect
measurement of improvement of SSpERG
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2021
- Study start15 Nov 2019
- Primary completion31 Oct 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Devogelaere Vision
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thibaut Devogelaere, Devogelaere Vision
- Investigators
- Thibaut Devogelaere, MD, FEBO, Principal investigator, Vision Devogelaere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05080153
- Sponsor's protocol ID
- 151119-OcF
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Vitamin Supplementation Containing L-Methylfolate (Ocufolin® Forte) on Retinal Venous Pressure and Homocysteine Plasma Levels in Patients With Glaucoma
- ClinicalTrials.gov ID
- NCT05080153
- Acronym / sponsor ID
- 151119-OcF
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Devogelaere VisionUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 15 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ocufolin fortestart of ocufolin forte 1 dd after RVP measurement, till 90 tablets are finished (3 months) | Dietary supplement | – |
Primary outcome
RVP effect
Time frame: 3 months
measurement of RVP lowering effect
SSpERG effect
Time frame: 3 months
measurement of improvement of SSpERG
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thibaut Devogelaere, MD, FEBO principal investigator
Vision Devogelaere
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Homocysteinemia, run by Devogelaere Vision at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RVP effect (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2021.