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OpenTrials
Completed

NCT Number: NCT01899222

Assessment of Prototype Hand-Held Fundus Camera

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

Completed

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Key information

Conditions

Normal Subject Population

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Handheld fundus photography

Device

diagnostic imaging with two types of retina camera

Other names: imaging only

Primary outcomes

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

    Time frame: 2-3 years

    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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2013
Registry last updated
Dec 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.