Multiple SclerosisNCT03135327
Clinical Applications of Advanced Ophthalmic Imaging
A study testing Ocufolin in people with Multiple Sclerosis and Dry Eye Syndromes, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls. There are two phases in this study. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy
- What is being tested?
- Ocufolin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2007to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-reported normal healthy subjects;
- Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
- Who can keep the eye open for imaging.
- The participant will be eligible for entry in the study if s/he:
- Is at least 18 years old and has full legal capacity to volunteer;
- Has read and signed the IRB Informed Consent Document;
Show all 14Show fewer
- Is willing and able to follow participant instructions;
- Has clear corneas and crystalline lens;
- Initial visual acuities were 20/80 or better;
- MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease;
- Hemoglobin A1c is 10 or less;
- Normotensive with or without medications;
- Without retinal capillary dropout or macular edema;
- Blood homocysteine > 9.
Who cannot join
- who can not read and sign the ICF;
- who can not receiving ophthalmic imaging;
- who cannot tolerate bright light during imaging.
- Interventional Phase 2 Group:
- The subjects will be ineligible for entry into the study if s/he:
- Has an active ocular disease;
- Has had surgery or an eye injury within 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Bascom Palmer Eye Institute
Miami, Florida, 33136
Jianhua Wang, MD, PHD, 305-482-5010, jwang3@med.miami.edu
Jianhua Wang, MD, PhD
About this study
The purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls.
There are two phases in this study. The first phase is an observational phase which studies the eye in various conditions. The second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (Ocufolin) for 6 months.
- Conditions
- Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy, Presbyopia, Myopia, Dementia
- Being tested
- Ocufolin
- Medical subject headings
- Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy, Presbyopia, Myopia, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OcufolinDietary supplement
Ocufolin medical food capsules will be taken once a day by mouth each morning with a meal for the first week, two capsules orally each morning with a meal for the second week and three capsules orally each morning with a meal for the rest of the 6 months study duration.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Phase - Ocufolin Group | Experimental | Participants in this group will receive the Ocufolin medical food for 6 months. Receives: Dietary Supplement: Ocufolin |
| Observational Phase Group | No intervention | Participants in this group will be studied and followed up for 1-2 years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal microstructure using OCT.
Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.
Measured: up to 2 years
Retinal vasculature by optical coherence tomography angiography (OCTA)
Retinal vascular network density in percentage.
Measured: up to 2 years
Conjunctival vasculature by functional slit-lamp (FSLB)
Conjunctival vascular network density in percentage.
Measured: up to 2 years
Corneal epithelial thickness
Measured in micrometers using ultra high resolution OCT
Measured: up to 2 years
Tear film thickness
Measured in micrometers using ultra high resolution OCT
Measured: up to 2 years
Secondary outcomes (2)
Retinal blood flow velocity by retinal function imager (RFI)
Retinal blood flow velocity in mm/s
Measured: up to 2 years
Conjunctival blood flow velocity by functional slit-lamp (FSLB)
Conjunctival blood flow velocity in mm/s
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start1 Jan 2007
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhua (Jay) Wang, MD, PhD, University of Miami
- Investigators
- Jianhua Wang, MD, PhD, Principal investigator, Bascom Palmer Eye Institute, University of Miami, Miami, FL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135327
- Sponsor's protocol ID
- 20070492
- Status last verified
- Sep 2026
- First submitted
- 24 Apr 2017
- Last updated
- 16 Sep 2026
- 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications of Advanced Ophthalmic Imaging
- ClinicalTrials.gov ID
- NCT03135327
- Acronym / sponsor ID
- 20070492
- Conditions
- Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy, Presbyopia, Myopia, Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 May 2017 (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 purpose of this study is to determine the clinical application of advanced ophthalmic imaging devices such as optical coherence tomography (OCT), retinal function imager (RFI), slit-lamp biomicroscopy (SLB), PERG in diseased eyes and normal controls.
There are two phases in this study. The first phase is an observational phase which studies the eye in various conditions. The second phase is an interventional phase which studies the changes in the eyes after taking an over-the-counter medical food (Ocufolin) for 6 months.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Phase - Ocufolin Group | Experimental | Dietary Supplement: OcufolinParticipants in this group will receive the Ocufolin medical food for 6 months. |
| Observational Phase Group | No intervention | –Participants in this group will be studied and followed up for 1-2 years. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Self-reported normal healthy subjects;
- Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke;
- Who can keep the eye open for imaging.
- Is at least 18 years old and has full legal capacity to volunteer;
- Has read and signed the IRB Informed Consent Document;
Key exclusion criteria (7 listed)
- who can not read and sign the ICF;
- who can not receiving ophthalmic imaging;
- who cannot tolerate bright light during imaging.
- Has an active ocular disease;
- Has had surgery or an eye injury within 6 months.
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 |
|---|---|---|
| OcufolinOcufolin medical food capsules will be taken once a day by mouth each morning with a meal for the first week, two capsules orally each morning with a meal for the second week and three capsules orally each morning with a meal for the rest of the 6 months study duration. | Dietary supplement | Interventional Phase - Ocufolin Group |
Primary outcome
Retinal microstructure using OCT.
Time frame: up to 2 years
Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.
Retinal vasculature by optical coherence tomography angiography (OCTA)
Time frame: up to 2 years
Retinal vascular network density in percentage.
Conjunctival vasculature by functional slit-lamp (FSLB)
Time frame: up to 2 years
Conjunctival vascular network density in percentage.
Corneal epithelial thickness
Time frame: up to 2 years
Measured in micrometers using ultra high resolution OCT
Tear film thickness
Time frame: up to 2 years
Measured in micrometers using ultra high resolution OCT
2 secondary outcomes
Retinal blood flow velocity by retinal function imager (RFI)
Time frame: up to 2 years
Conjunctival blood flow velocity by functional slit-lamp (FSLB)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Multiple Sclerosis
RecruitingPhase 3
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.
Relapsing Multiple Sclerosis
Active, not recruitingObservational study
A Study to Evaluate Long-Term Safety of Vumerity and Tecfidera in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Study of Skin Tumors in Tuberous Sclerosis
Tuberous Sclerosis
Recruiting
The Effects of Synchronous and Asynchronous Pilates Training Based on Telerehabilitation on Core Stabilization, Balance, Cognitive Functions, and Quality of Life in Individuals With Multiple Sclerosis: A Single-Blind Randomized Controlled Trial
Multiple Sclerosis
RecruitingObservational study
Care in Multiple Sclerosis (MS)
Multiple Sclerosis
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.
Jianhua Wang, MD, PhD principal investigator
Bascom Palmer Eye Institute, University of Miami, Miami, FL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ocufolin in people with Multiple Sclerosis and Dry Eye Syndromes, run by University of Miami at 1 site in United States.
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 14 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Wang, MD, PhD (3054825010, jwang3@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal microstructure using OCT. (time frame: up to 2 years). The study lists 5 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 16 Sep 2026.