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OCT Reference Database

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ClinicalTrials.gov Identifier: NCT01986478
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : March 27, 2014
Sponsor:
Information provided by (Responsible Party):
Topcon Medical Systems, Inc.

Brief Summary:
To collect data for a reference database.

Condition or disease
Healthy

Detailed Description:
Collection of multiple subjects to create a reference database.

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Study Type : Observational
Actual Enrollment : 389 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study
Study Start Date : October 2013
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Group/Cohort
Normal
Normal results from clinical exam and free of ocular pathology



Primary Outcome Measures :
  1. Retinal Thickness [ Time Frame: Day 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects that are Normal
Criteria

Inclusion Criteria:

  1. Subjects 18 years of age or older on the date of informed consent
  2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  3. Subjects presenting at the site with normal eyes (eyes without pathology)
  4. IOP ≤ 21 mmHg bilaterally
  5. BCVA 20/40 or better (each eye)
  6. Both eyes must be free of eye disease

Exclusion Criteria:

  1. Subjects unable to tolerate ophthalmic imaging
  2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  3. HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD < 5%
  4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 33% or false positives > 25%, or false negatives > 25%
  5. Presence of any ocular pathology except for cataract
  6. Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
  7. Narrow angle
  8. History of leukemia, dementia or multiple sclerosis
  9. Concomitant use of hydroxychloroquine and chloroquine

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): NCT01986478


Locations
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United States, Arizona
Horizon Eye Specialist & Laser Center
Scottsdale, Arizona, United States, 85054
United States, California
Valley Eyecare Center
Livermore, California, United States, 94550
Keck School of Medicine
Los Angeles, California, United States, 90033
Western University of Health Sciences
Pomona, California, United States, 91716
United States, New York
Stat University of New York College of Optometry
New York, New York, United States, 10036
Sponsors and Collaborators
Topcon Medical Systems, Inc.
Investigators
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Principal Investigator: Michael Sinai, PhD Senior Manager Product Planning Group
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Responsible Party: Topcon Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT01986478    
Other Study ID Numbers: DC-001
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: March 27, 2014
Last Verified: March 2014