We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Validation Study of RTVue Features

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370850
First Posted: June 10, 2011
Last Update Posted: June 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Optovue
  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) ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mike Sinai, PhD / Director of Clinical Affairs, Optovue
ClinicalTrials.gov Identifier: NCT01370850     History of Changes
Other Study ID Numbers: RTVue Validation Study
First Submitted: April 28, 2011
First Posted: June 10, 2011
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Optovue:
Retina pathology