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iCam Clinical Validation Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01600261
First Posted: May 17, 2012
Last Update Posted: June 28, 2012
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.
Information provided by (Responsible Party):
Optovue
  Purpose
Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.

Condition
Eye Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: iCam Clinical Validation Study

Resource links provided by NLM:


Further study details as provided by Optovue:

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

Enrollment: 131
Study Start Date: April 2012
Study Completion Date: June 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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).
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01600261


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

Responsible Party: Optovue
ClinicalTrials.gov Identifier: NCT01600261     History of Changes
Other Study ID Numbers: 200-47425
First Submitted: May 14, 2012
First Posted: May 17, 2012
Last Update Posted: June 28, 2012
Last Verified: June 2012

Keywords provided by Optovue:
without eye disease

Additional relevant MeSH terms:
Eye Diseases