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Official title Clinical Applications of Advanced Ophthalmic Imaging
ClinicalTrials.gov ID: NCT03135327
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99. Healthy volunteers may be eligible.
You may be able to join if
- Observational Phase 1 Group
- Self-reported normal healthy people;
- 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.
You likely can't join if
- who can not read and sign the ICF;
- who can not receiving ophthalmic imaging;
- who cannot tolerate bright light during imaging. treatment Phase 2 Group: Inclusion criteria The participant will be eligible for entry in the study...
- 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;
See the full eligibility criteria
- Observational Phase 1 Group
- Self-reported normal healthy people;
- 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.
- who can not read and sign the ICF;
- who can not receiving ophthalmic imaging;
- who cannot tolerate bright light during imaging. treatment Phase 2 Group: 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 people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.