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Assessment of Prototype Hand-Held Fundus Camera

Sponsor
University of Rochester (Other)
Overall Status
Completed
CT.gov ID
NCT01899222
Collaborator
(none)
8
Enrollment
1
Location
5.9
Actual Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessment of handheld fundus images in comparison to conventional fundus camera images.

Condition or Disease Intervention/Treatment Phase
  • Device: Handheld fundus photography

Detailed Description

This study is comparing a small handheld camera with a standard fundus camera for image quality

Study Design

Study Type:
Observational
Actual Enrollment :
8 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Prototype Hand-Held Fundus Camera
Actual Study Start Date :
Apr 10, 2015
Actual Primary Completion Date :
Oct 8, 2015
Actual Study Completion Date :
Oct 8, 2015

Arms and Interventions

Arm Intervention/Treatment
fundus imaging

retinal photograph obtained at visit

Device: Handheld fundus photography
diagnostic imaging with two types of retina camera
Other Names:
  • imaging only

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of photographs that score a "3" or higher on the grading scale [2-3 years]

      Photos will be evaluated by ophthalmologists and scored as follows: Unacceptable: cannot see fundus detail Unacceptable: fundus detail visualized, but inadequate for meaningful analysis Acceptable: fundus detail visualized enough to make general comments, with modest improvement image would be of sufficient quality for widespread use Good: fundus detail visualized, meaningful analysis possible, standard photograph superior Excellent: fundus detail visualized as well as standard photograph Superior: fundus detail of higher quality than standard photograph

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:

    • Age > 18

    • The ability to give informed consent and be willing to spend up to two hours in the eye clinic during the duration of the study.

    • The subjects may have a normal retina and optic nerve, or subjects may have abnormalities of the posterior pole of the retina or the optic nerve.

    Exclusion criteria:

    • Medical or ophthalmic instability that would create a contraindication for minimally invasive ophthalmic diagnostic testing will exclude participation as a subject.

    • Ophthalmic pathology felt by the principal investigator that would make retinal imaging with standard photographs difficult or not possible.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Rochester Rochester New York United States 14642

    Sponsors and Collaborators

    • University of Rochester

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    David Kleinman, Medical Doctor and Department Faculty, University of Rochester
    ClinicalTrials.gov Identifier:
    NCT01899222
    Other Study ID Numbers:
    • HHFC 02
    First Posted:
    Jul 15, 2013
    Last Update Posted:
    Dec 9, 2020
    Last Verified:
    Dec 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Dec 9, 2020