Optical Coherence Tomography (OCT) Data Collection Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Optovue
ClinicalTrials.gov Identifier:
NCT01459731
First received: October 23, 2011
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

Collect OCT data to evaluate the range and age trend of eye measurements.


Condition
No Eye Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optical Coherence Tomography Data Collection Study

Resource links provided by NLM:


Further study details as provided by Optovue:

Primary Outcome Measures:
  • range of eye measurements [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • age trend of eye measurements [ Time Frame: Day 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: September 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Age 18-29
Age 30-39
Age 40-49
Age 50-59
Age 60-69
Age 70+

  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

No eye disease

Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Able and willing to provide consent
  • Able and willing to complete the required examininations and visit
  • Refractive error within 8 diopters sphere and within 2 diopters cylinder in each eye
  • Best corrected visual acuity of 20/30 or better in each eye

Exclusion Criteria:

  • History of leukemia, AIDS, dementia or multiple sclerosis
  • Concomitant use of hydroxycloroquine or chloroquine
  • Family history of glaucoma among first degree relatives
  • Intraocular pressure of 22mm Hg or greater in either eye
  • Unreliable or abnormal visual field
  • Active ocular disease
  • Previously diagnosed with glaucoma or glaucoma suspect
  • Congenital ocular abnormalities
  • Previous intra-ocular surgery or laser treatment (other than refractive surgery or uncomplicated cataract surgery greater than 6 months previously)
  • Anatomic narrow angle
  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: NCT01459731

Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
College of Optometry, Western University of Health Sciences
Pomona, California, United States, 91766
Buena Vista Eye Care
San Jose, California, United States, 95112
United States, Illinois
Illinois Eye Institute
Chicago, Illinois, United States, 60616
United Kingdom
Institute of Ophthalmology, University College London
London, England, United Kingdom, EC1V 9EL
Sponsors and Collaborators
Optovue
Investigators
Principal Investigator: George Comer, OD, MBA Southern California College of Optometry
Principal Investigator: Michael Chaglasian, OD Illinois Eye Institute
Principal Investigator: Jorge Cuadros, OD, PhD Buena Vista Eye Care
Principal Investigator: David Garway-Heath, MD Institute of Ophthalmology, University College London
Principal Investigator: Pinakin G Davey, OD, PhD Western University of Health Sciences
  More Information

No publications provided

Responsible Party: Optovue
ClinicalTrials.gov Identifier: NCT01459731     History of Changes
Other Study ID Numbers: OCT 200-47091
Study First Received: October 23, 2011
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Eye Diseases

ClinicalTrials.gov processed this record on July 26, 2014