Clinical Validation Study of RTVue Features

This study has been completed.
Sponsor:
Information provided by:
Optovue
ClinicalTrials.gov Identifier:
NCT01370850
First received: April 28, 2011
Last updated: June 9, 2011
Last verified: June 2011
  Purpose

To perform a clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology.


Condition
Healthy
Glaucoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Validation Study of RTVue Features

Resource links provided by NLM:


Further study details as provided by Optovue:

Primary Outcome Measures:
  • Retina measurement [ Time Frame: at time of study visit (day 1) ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: March 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal
Normal results from the clinical exam and free of ocular pathology.
Glaucoma
Clinical exam results consistent with glaucoma; visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
Retina
Clinical exam results consistent with retina pathology.

Detailed Description:

Clinical validation study of RTVue features in volunteers with various ocular pathology or no ocular pathology. Subjects to undergo a clinical exam and OCT scanning.

  Eligibility

Ages Eligible for Study:   18 Years and older
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 subjects will have normal results from the clinical exam and be free of ocular pathology.
  • Glaucoma patients will have clinical exam results consistent with glaucoma; they will have visual field defects consistent with glaucoma and/or structural damage consistent with glaucoma.
  • Retina patients will have clinical exam results consistent with retina pathology.

Exclusion Criteria:

  • Normal subjects will be free of any ocular pathology.
  • Glaucoma patients will be free of any ocular pathology except glaucoma.
  • Retina patients will be free of any ocular pathology except any type of 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: NCT01370850

Locations
United States, California
Pacific Eye Specialists
Daly City, California, United States, 94015
Sponsors and Collaborators
Optovue
Investigators
Study Director: Mike Sinai, PhD Optovue
  More Information

No publications provided

Responsible Party: Mike Sinai, PhD / Director of Clinical Affairs, Optovue
ClinicalTrials.gov Identifier: NCT01370850     History of Changes
Other Study ID Numbers: RTVue Validation Study
Study First Received: April 28, 2011
Last Updated: June 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Optovue:
Retina pathology

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on July 23, 2014