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
  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
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
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 October 19, 2014