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Trial record 91 of 8394 for:    Ophthalmopathy

iCam Clinical Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01600261
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : June 28, 2012
Information provided by (Responsible Party):

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

Condition or disease
Eye Disease

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 131 participants
Time Perspective: Prospective
Official Title: iCam Clinical Validation Study
Study Start Date : April 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

eye exam

Primary Outcome Measures :
  1. proportion of clinically useful images [ Time Frame: Day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study subjects shall be recruited from the practice of the principal investigator (PI).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01600261

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United States, California
Livermore Optometry Group
Livermore, California, United States, 94550
Buena Vista Eye Care
San Jose, California, United States, 95112
Sponsors and Collaborators

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Responsible Party: Optovue Identifier: NCT01600261     History of Changes
Other Study ID Numbers: 200-47425
First Posted: May 17, 2012    Key Record Dates
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Optovue:
without eye disease

Additional relevant MeSH terms:
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Eye Diseases