Clinical Validation Study for iVue
This study has been completed.
Information provided by:
First received: November 15, 2010
Last updated: November 16, 2010
Last verified: November 2010
To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.
Normal and Ocular Pathology.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Clinical Validation Study for iVue|
Resource links provided by NLM:
Further study details as provided by Optovue:
Primary Outcome Measures:
- thickness of ocular structures [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Study Completion Date:||September 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Normal results from clinical exam and free of ocular pathology.
Clinical exam results consistent with retina pathology
Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
Clinical exam results consistent with cornea pathology.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01242553
|United States, California|
|Pacific Eye Specialists|
|Daly City, California, United States, 94015|
|United States, Colorado|
|Colorado Retina Center|
|Denver, Colorado, United States, 80204|
Sponsors and Collaborators
|Principal Investigator:||Michael Hee, MD||Pacific Eye Specialists|
|Principal Investigator:||Nalin Mehta, MD||Colorado Retina Center|
|Study Director:||Michael Sinai, PhD||Optovue|