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Clinical Applications of Advanced Ophthalmic Imaging

Clinical Applications of Advanced Ophthalmic Imaging

Recruiting
18-99 years
All
Phase N/A

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Overview

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.

Eligibility

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.

Study details
    Multiple Sclerosis
    Dry Eye Syndromes
    Diabetic Retinopathy
    Presbyopia
    Myopia
    Dementia

NCT03135327

University of Miami

28 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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