Clinical Applications of Advanced Ophthalmic Imaging

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    5000
  • sponsor
    University of Miami
Updated on 24 January 2022
edema
cognitive impairment
dry eye syndrome
hemoglobin a1c
macular edema
optical coherence tomography
alzheimer's disease
mild cognitive impairment
myopia
ocular disease
dry eyes
disease or disorder
multiple sclerosis
slit lamp examination
Accepts healthy volunteers

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. 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.

Details
Condition Multiple Sclerosis, Dry Eye Syndromes, Diabetic Retinopathy, Presbyopia, Myopia, Dementia
Treatment No intervention, Ocufolin
Clinical Study IdentifierNCT03135327
SponsorUniversity of Miami
Last Modified on24 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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

Exclusion Criteria

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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