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Clinical Applications of Advanced Ophthalmic Imaging

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ClinicalTrials.gov Identifier: NCT03135327
Recruitment Status : Recruiting
First Posted : May 1, 2017
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Jianhua (Jay) Wang, MD, PhD, University of Miami

Brief Summary:
This study 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Dry Eye Syndromes Diabetic Retinopathy Presbyopia Myopia Dementia Other: No intervention

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Applications of Advanced Ophthalmic Imaging
Actual Study Start Date : January 1, 2007
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: No intervention
    No intervention


Primary Outcome Measures :
  1. Retinal microstructure using OCT. [ Time Frame: 10 years ]
    Optical coherence tomography is used to measure the thickness of intraretinal layers. The measurement is in micrometer.

  2. Retinal vasculature by optical coherence tomography angiography (OCTA) [ Time Frame: 10 years ]
    Retinal vascular network density in percentage.

  3. Conjunctival vasculature by functional slit-lamp (FSLB) [ Time Frame: 10 years ]
    Conjunctival vascular network density in percentage.

  4. Corneal epithelial thickness and tear film thickness [ Time Frame: 10 years ]
    Corneal epithelial thickness in micrometers measured using ultra-high resolution OCT.


Secondary Outcome Measures :
  1. Retinal blood flow velocity by retinal function imager (RFI) [ Time Frame: 10 years ]
    Retinal blood flow velocity in mm/s

  2. Conjunctival blood flow velocity by functional slit-lamp (FSLB) [ Time Frame: 10 years ]
    Conjunctival blood flow velocity in mm/s



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
patients with diseases and normal controls.
Criteria

Inclusion Criteria:

Self-reported normal healthy subjects Clinical diagnosis of Alzheimer's Disease, mild cognitive impairment, multiple sclerosis, dry eye, myopia, diabetic.

Who can keep the eye open for imaging.

Exclusion Criteria: who can not read and sign the ICF.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135327


Contacts
Contact: Jianhua Wang, MD, PhD 3054825010 jwang3@med.miami.edu

Locations
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Jianhua Wang, MD, PHD    305-482-5010    jwang3@med.miami.edu   
Sponsors and Collaborators
University of Miami

Responsible Party: Jianhua (Jay) Wang, MD, PhD, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03135327     History of Changes
Other Study ID Numbers: 20070492
First Posted: May 1, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Multiple Sclerosis
Dementia
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Presbyopia
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases