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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.

Tracking Information
First Submitted Date November 11, 2013
First Posted Date November 18, 2013
Last Update Posted Date March 27, 2014
Study Start Date October 2013
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2013)
Retinal Thickness [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title OCT Reference Database
Official Title Topcon 3D OCT-1 Maestro and 3D OCT-2000 Optical Coherence Tomography Systems: Reference Database Study
Brief Summary To collect data for a reference database.
Detailed Description Collection of multiple subjects to create a reference database.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Subjects that are Normal
Condition Healthy
Intervention Not Provided
Study Groups/Cohorts Normal
Normal results from clinical exam and free of ocular pathology
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 25, 2014)
389
Original Estimated Enrollment
 (submitted: November 15, 2013)
400
Actual Study Completion Date March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01986478
Other Study ID Numbers DC-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Topcon Medical Systems, Inc.
Study Sponsor Topcon Medical Systems, Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Michael Sinai, PhD Senior Manager Product Planning Group
PRS Account Topcon Medical Systems, Inc.
Verification Date March 2014