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Assessment of Prototype Hand-held Fundus Camera

This study has been 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to make additional changes to the hand held camera therefore he terminated the study rather than continue with an outdated camera design.)
Sponsor:
Information provided by (Responsible Party):
david kleinman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01244412
First received: November 17, 2010
Last updated: May 15, 2015
Last verified: May 2015
  Purpose
This is the proof of concept study to evaluate the performance of an early stage prototype of a hand-held fundus camera.

Condition
Evaluate Performance of New Fundus Camera

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Assessment of Prototype Hand-held Fundus Camera

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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


Enrollment: 1
Study Start Date: December 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed Description:
We tested a novel fundus camera. The images obtained were acceptable to move to the next step in development.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
18 years or older
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244412

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

Responsible Party: david kleinman, Medical Doctor, University of Rochester
ClinicalTrials.gov Identifier: NCT01244412     History of Changes
Other Study ID Numbers: LUM-001 
Study First Received: November 17, 2010
Results First Received: June 5, 2013
Last Updated: May 15, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Fundus photography

ClinicalTrials.gov processed this record on September 30, 2016