Clinical Validation Study for iVue

This study has been completed.
Sponsor:
Information provided by:
Optovue
ClinicalTrials.gov Identifier:
NCT01242553
First received: November 15, 2010
Last updated: November 16, 2010
Last verified: November 2010
  Purpose

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


Condition
Normal and Ocular Pathology.

Study Type: Observational
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 ]

Enrollment: 48
Study Start Date: October 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
Normal results from clinical exam and free of ocular pathology.
Retina
Clinical exam results consistent with retina pathology
Glaucoma
Clinical exam results consistent with glaucoma and visual field defects consistent with glaucoma.
Cornea
Clinical exam results consistent with cornea pathology.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Volunteers with various ocular pathology or no ocular pathology.

Criteria

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
  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 ClinicalTrials.gov identifier: NCT01242553

Locations
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
Optovue
Investigators
Principal Investigator: Michael Hee, MD Pacific Eye Specialists
Principal Investigator: Nalin Mehta, MD Colorado Retina Center
Study Director: Michael Sinai, PhD Optovue
  More Information

No publications provided

Responsible Party: Director of Clinical Affairs, Optovue
ClinicalTrials.gov Identifier: NCT01242553     History of Changes
Other Study ID Numbers: iVue 100-2009
Study First Received: November 15, 2010
Last Updated: November 16, 2010
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 20, 2014