Assessment of Prototype Hand-held Fundus Camera

Terminated

• Conditions: Evaluate Performance of New Fundus Camera

• Registration Number: NCT01244412
• Lead Sponsor: 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2010-11-17
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Study Start: 2010-12
• Primary Completion: 2011-11
• Study Completion: 2011-12
• Results First Submitted: 2013-06-05
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-15
• Last Update Submitted: 2015-05-15
• Results First Posted: 2015-06-02
• Last Update Posted: 2015-06-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Have an Acceptable Image (Image Score of 3 or Higher) of Their Eye With the Hand Held Camera	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

Trial Locations

Locations (1)

Flaum Eye Institute-University of Rochester; 🇺🇸 Rochester, New York, United States