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Assessment of Prototype Hand-held Fundus Camera

This study has been completed.
Sponsor:
Collaborator:
Lumetrics
Information provided by (Responsible Party):
University of Rochester
ClinicalTrials.gov Identifier:
NCT01244412
First received: November 17, 2010
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention
No Specific Condition is Being Studied
 Device: Hand held fundus photos

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Assessment of Prototype Hand-held Fundus Camera

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Comparison to traditional 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 and patient comfort.


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)
Intervention Details:
    Device: Hand held fundus photos
    Patients will have photos taken with hand held device
  Eligibility

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
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
Lumetrics
  More Information

No publications provided

Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT01244412     History of Changes
Other Study ID Numbers: LUM-001
Study First Received: November 17, 2010
Last Updated: June 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
Fundus photography

ClinicalTrials.gov processed this record on May 19, 2013