Assessment of Prototype Hand-Held Fundus Camera

Completed

• Conditions: Normal Subject Population
• Interventions: Device: Handheld fundus photography

• Registration Number: NCT01899222
• Lead Sponsor: University of Rochester

Brief Summary

Assessment of handheld fundus images in comparison to conventional fundus camera images.

Detailed Description

This study is comparing a small handheld camera with a standard fundus camera for image quality

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-12
• Study First Posted: 2013-07-15
• Study Start: 2015-04-10
• Primary Completion: 2015-10-08
• Study Completion: 2015-10-08
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-08
• Last Update Posted: 2020-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fundus imaging	Handheld fundus photography	retinal photograph obtained at visit

Primary Outcome Measures

Name	Time	Method
Percentage of photographs that score a "3" or higher on the grading scale	2-3 years	Photos will be evaluated by ophthalmologists and scored as follows: 1. Unacceptable: cannot see fundus detail; 2. Unacceptable: fundus detail visualized, but inadequate for meaningful analysis; 3. Acceptable: fundus detail visualized enough to make general comments, with modest improvement image would be of sufficient quality for widespread use; 4. Good: fundus detail visualized, meaningful analysis possible, standard photograph superior; 5. Excellent: fundus detail visualized as well as standard photograph; 6. Superior: fundus detail of higher quality than standard photograph

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States