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

Tracking Information
First Received Date ^ICMJE	May 14, 2012
Last Updated Date	June 27, 2012
Start Date ^ICMJE	April 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 16, 2012)	proportion of clinically useful images [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01600261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	iCam Clinical Validation Study
Official Title ^ICMJE	iCam Clinical Validation Study
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.
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Study subjects shall be recruited from the practice of the principal investigator (PI).
Condition ^ICMJE	Eye Disease
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	eye exam
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	131
Completion Date	June 2012
Primary Completion Date	May 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01600261
Other Study ID Numbers ^ICMJE	200-47425
Has Data Monitoring Committee	No
Responsible Party	Optovue
Study Sponsor ^ICMJE	Optovue
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Optovue
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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