Clinical Validation Study for iVue

Completed

• Conditions: Normal and Ocular Pathology

• Registration Number: NCT01242553
• Lead Sponsor: Optovue

Brief Summary

To demonstrate clinical substantial equivalence of iVue as comparable to commercially available RTVue.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2010-11
• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-16
• Study First Posted: 2010-11-17
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• Normal: Normal results from clinical exam and free of ocular pathology.
• Glaucoma: Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
• Cornea: Clinical exam results consistent with cornea pathology.
• Retina: Clinical exam results consistent with retina pathology

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
thickness of ocular structures

Trial Locations

Locations (2)

Pacific Eye Specialists; 🇺🇸 Daly City, California, United States

Colorado Retina Center; 🇺🇸 Denver, Colorado, United States