Assessment of Prototype Hand-Held Fundus Camera

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

Study Overview

• Status: Completed
• Conditions: Normal Subject Population
• Intervention / Treatment: Device: Handheld fundus photography

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • 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

Ophthalmology clinic

Description

Inclusion criteria:

• Age > 18
• The ability to give informed consent and be willing to spend up to two hours in the eye clinic during the duration of the study.
• The subjects may have a normal retina and optic nerve, or subjects may have abnormalities of the posterior pole of the retina or the optic nerve.

Exclusion criteria:

• Medical or ophthalmic instability that would create a contraindication for minimally invasive ophthalmic diagnostic testing will exclude participation as a subject.
• Ophthalmic pathology felt by the principal investigator that would make retinal imaging with standard photographs difficult or not possible.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fundus imaging; retinal photograph obtained at visit	Device: Handheld fundus photography; diagnostic imaging with two types of retina camera; Other Names: imaging only

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2015
• Primary Completion (Actual): October 8, 2015
• Study Completion (Actual): October 8, 2015

Study Registration Dates

• First Submitted: July 12, 2013
• First Submitted That Met QC Criteria: July 12, 2013
• First Posted (Estimate): July 15, 2013

Study Record Updates

• Last Update Posted (Actual): December 9, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HHFC 02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No