Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

iCam Clinical Validation Study

This study has been completed.
Information provided by (Responsible Party):
Optovue Identifier:
First received: May 14, 2012
Last updated: June 27, 2012
Last verified: June 2012

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

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 ] [ 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.


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).


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01600261

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

No publications provided

Responsible Party: Optovue 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 processed this record on March 01, 2015