Clinical Applications of Advanced Ophthalmic Imaging

RecruitingNot a drug-phase studyMS (type not specified)NCT03135327

What it found

Still running

No result yet.

What was tested

Treatment tested

  • Ocufolin

What it measured

Main measures

  • Retinal microstructure using OCT.

    up to 2 years

    Retina scans (OCT)
  • Retinal vasculature by optical coherence tomography angiography (OCTA)

    up to 2 years

    Retina scans (OCT)
  • Conjunctival vasculature by functional slit-lamp (FSLB)

    up to 2 years

  • Corneal epithelial thickness

    up to 2 years

    Retina scans (OCT)
  • Tear film thickness

    up to 2 years

    Retina scans (OCT)

Other measures (2)

  • Retinal blood flow velocity by retinal function imager (RFI)

    up to 2 years

  • Conjunctival blood flow velocity by functional slit-lamp (FSLB)

    up to 2 years

Who could take part

MS (type not specified) · 18 to 99

Show the full criteria

Inclusion criteria

Observational Phase 1 Group Inclusion Criteria: 1. Self-reported normal healthy subjects; 2. Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetics and stroke; 3. Who can keep the eye open for imaging.

Exclusion criteria

1. who can not read and sign the ICF; 2. who can not receiving ophthalmic imaging; 3. who cannot tolerate bright light during imaging. Interventional Phase 2 Group: Inclusion criteria The participant will be eligible for entry in the study if s/he: 1. Is at least 18 years old and has full legal capacity to volunteer; 2. Has read and signed the IRB Informed Consent Document; 3. Is willing and able to follow participant instructions; 4. Has clear corneas and crystalline lens; 5. Initial visual acuities were 20/80 or better; 6. MTHFR C677TT homozygous, or MTHFR C677T/A1298C compound heterozygous with mild to moderate micro-aneurismal vascular retinopathy disease; 7. Hemoglobin A1c is 10 or less; 8. Normotensive with or without medications; 9. Without retinal capillary dropout or macular edema; 10. Blood homocysteine > 9. Exclusion criteria The subjects will be ineligible for entry into the study if s/he: 1. Has an active ocular disease; 2. Has had surgery or an eye injury within 6 months.

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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History

    1. Started

      Jan 2007

    2. Main results due

      Dec 2029

    3. Finished

      Dec 2029

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