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Assessment of Prototype Hand-Held Fundus Camera

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01899222
Recruitment Status : Active, not recruiting
First Posted : July 15, 2013
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
David Kleinman, University of Rochester

Brief Summary:
Assessment of handheld fundus images in comparison to conventional fundus camera images.

Condition or disease Intervention/treatment
Normal Subject Population Device: Handheld fundus photography

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

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Prototype Hand-Held Fundus Camera
Actual Study Start Date : April 10, 2015
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
fundus imaging
retinal photograph obtained at visit
Device: Handheld fundus photography
diagnostic imaging with two types of retina camera
Other Name: imaging only




Primary Outcome Measures :
  1. Percentage of photographs that score a "3" or higher on the grading scale [ Time Frame: 2-3 years ]

    Photos will be evaluated by ophthalmologists and scored as follows:

    1. Unacceptable: cannot see fundus detail
    2. Unacceptable: fundus detail visualized, but inadequate for meaningful analysis
    3. Acceptable: fundus detail visualized enough to make general comments, with modest improvement image would be of sufficient quality for widespread use
    4. Good: fundus detail visualized, meaningful analysis possible, standard photograph superior
    5. Excellent: fundus detail visualized as well as standard photograph
    6. Superior: fundus detail of higher quality than standard photograph



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ophthalmology clinic
Criteria

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.

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): NCT01899222


Locations
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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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Responsible Party: David Kleinman, Medical Doctor and Department Faculty, University of Rochester
ClinicalTrials.gov Identifier: NCT01899222    
Other Study ID Numbers: HHFC 02
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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