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. Identifier: NCT01244412
Recruitment Status : Terminated (The PI wanted to make additional changes to the hand held camera therefore he terminated the study rather than continue with an outdated camera design.)
First Posted : November 19, 2010
Results First Posted : June 2, 2015
Last Update Posted : June 2, 2015
Information provided by (Responsible Party):
david kleinman, University of Rochester

Brief Summary:
This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.

Condition or disease
Evaluate Performance of New Fundus Camera

Detailed Description:
We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Case-Only
Official Title: Assessment of Prototype Hand-held Fundus Camera
Study Start Date : December 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Primary Outcome Measures :
  1. Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera [ Time Frame: estimated 3 months ]

    Will determine if the hand held camera is comparable to the traditional table mount camera in quality of images. The quality of the image of the participant's eye taken with the hand held camera will be compared to the quality of the image taken with the table mount camera using the following scale. We will determine the number of participants who have a score of 3 or higher.

    Scale Image scored as follows

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

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
18 years or older

Inclusion Criteria:

  • Greater than 21 years of age
  • Ability to give informed consent
  • Willingness to spend up to 2 hours for photos
  • 5 patients presumed to be normal
  • 5 patients with abnormalities of the posterior pole of the retina or the optic nerve will be studied

Exclusion Criteria:

  • Any known pathology felt by the Principal Investigator to be significant so as to preclude participation as a normal subject
  • Monocular subjects
  • Potential subjects may be excluded based on the Principal Investigator's judgement that they are not good subjects to photograph
  • Children and vulnerable subjects will not be included in the study

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 identifier (NCT number): NCT01244412

United States, New York
Flaum Eye Institute-University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester

Responsible Party: david kleinman, Medical Doctor, University of Rochester Identifier: NCT01244412     History of Changes
Other Study ID Numbers: LUM-001
First Posted: November 19, 2010    Key Record Dates
Results First Posted: June 2, 2015
Last Update Posted: June 2, 2015
Last Verified: May 2015

Keywords provided by david kleinman, University of Rochester:
Fundus photography