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OpenTrials
Completed

NCT Number: NCT01600261

iCam Clinical Validation Study

Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.

Completed

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Key information

Conditions

Eye Disease Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Livermore Optometry Group, Livermore, California, United States

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About this study

Optovue has developed a new color fundus camera for imaging the eye with up to 45 degree field of view and without the use of dilating drops. The purpose of the study is to compare the image quality of the new camera with that of a commercially available color fundus camera. Consented subjects will undergo a general ophthalmic examination and series of fundus photography exams using the study device and comparison device. Photo image quality will be assessed for determination of clinically usefulness.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • At least 18 years of age
  • Able and willing to complete the required examination

Exclusion criteria

  • Spherical Equivalent outside -12 diopter to +15 diopter
  • Without lens
  • Inability to fixate

Treatment and study plan

Primary outcomes

  1. proportion of clinically useful images

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Optovue

Industry

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
May 17, 2012
Registry last updated
Jun 28, 2012

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.

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