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Retinal Therapy Guided by 3D OCT Image Analysis

Sponsor
Michael Abramoff (Other)
Overall Status
Completed
CT.gov ID
NCT02308215
Collaborator
National Eye Institute (NEI) (NIH)
77
Enrollment
1
Location
96.1
Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose is to find a better way to predict the timing of treatments given to patients with Wet Age-related macular degeneration using image analysis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study focuses on making better use of advanced three-dimensional imaging and analysis to allow physicians to know when a treatment is being effective and thus not overuse it. The study will examine how 3-D optical coherence tomography and related image analysis can be used to assess changes in the macula and retina of patients' eyes. These changes can reveal how well a person is responding to anti-VEGF treatment and thus help doctors provide proper treatment timing and care.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    77 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Retinal Therapy Guided by 3D OCT Image Analysis
    Study Start Date :
    Jul 1, 2010
    Actual Primary Completion Date :
    Jul 5, 2018
    Actual Study Completion Date :
    Jul 5, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Measure central retinal layer thickness in µms. [one year]

    2. Measure amount of fluid in the retina in µms. [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 120 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • fundoscopically confirmed AMD and patient eligible for treatment with anti-VEGF
    Exclusion Criteria:

    • Patients with a CNV due to other causes (OHS, trauma)

    • eyes that have been previously treated for CNV

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Iowa Hospitals Dept of Ophthalmology Iowa City Iowa United States 52246

    Sponsors and Collaborators

    • Michael Abramoff
    • National Eye Institute (NEI)

    Investigators

    • Principal Investigator: Michael D Abramoff, MD, PhD, University of Iowa
    • Principal Investigator: Milan Sonka, MS, PhD, University of Iowa

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Michael Abramoff, Professor, University of Iowa
    ClinicalTrials.gov Identifier:
    NCT02308215
    Other Study ID Numbers:
    • 201003712
    • 1R01EY019112-01A2
    First Posted:
    Dec 4, 2014
    Last Update Posted:
    Aug 30, 2019
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Michael Abramoff, Professor, University of Iowa
    Retina
    AMD
    OCT
    Additional relevant MeSH terms:
    Macular Degeneration
    Choroidal Neovascularization
    Neovascularization, Pathologic

    Study Results

    No Results Posted as of Aug 30, 2019