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iCam Clinical Validation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optovue
ClinicalTrials.gov Identifier:
NCT01600261
First received: May 14, 2012
Last updated: June 27, 2012
Last verified: June 2012
History of Changes
  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:

MedlinePlus related topics: Eye Diseases
U.S. FDA Resources

Further study details as provided by Optovue:

Primary Outcome Measures:
  • proportion of clinically useful images [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Optovue
ClinicalTrials.gov Identifier: NCT01600261     History of Changes
Other Study ID Numbers: 200-47425
Study First Received: May 14, 2012
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Optovue:
without eye disease

Additional relevant MeSH terms:
Eye Diseases

ClinicalTrials.gov processed this record on June 18, 2013