Assessment of Prototype Hand-held Fundus Camera

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

Study Overview

• Status: Terminated
• Conditions: 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
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Flaum Eye Institute-University of Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

18 years or older

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera	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; Unacceptable: cannot see fundus detail; Unacceptable: fundus detail visualized, but inadequate for meaningful analysis; Acceptable: fundus detail visualized to make general comments, modest improvement image would be of sufficient quality for use; Good: fundus detail visualized, meaningful analysis possible, std photo superior; Excellent: fundus detail visualized as well as std photo; Superior: fundus detail of higher quality than std photo	estimated 3 months

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 17, 2010
• First Submitted That Met QC Criteria: November 18, 2010
• First Posted (Estimate): November 19, 2010

Study Record Updates

• Last Update Posted (Estimate): June 2, 2015
• Last Update Submitted That Met QC Criteria: May 15, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Fundus photography
• Other Study ID Numbers: LUM-001