Assessment of Prototype Hand-Held Fundus Camera

N/ACompletedNCT01899222

University of Rochester8 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Normal Subject Population

Interventions

Handheld fundus photographyDEVICE

diagnostic imaging with two types of retina camera

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Rochester

Rochester, New York, United States

Outcomes

Primary Outcomes

Percentage of photographs that score a "3" or higher on the grading scale

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

Time frame: 2-3 years

Data from ClinicalTrials.gov

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