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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
History of Changes
  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:

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

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
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 June 17, 2013