Topcon 3D OCT-1 Maestro Reference Database Study II

June 6, 2022 updated by: Topcon Medical Systems, Inc.
The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.

Study Type

Observational

Enrollment (Actual)

504

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • UAB School of Optometry
    • California
      • Fullerton, California, United States, 92831
        • Southern California College of Optometry
      • Livermore, California, United States, 94550
        • Valley Eyecare Center
      • Pomona, California, United States, 91716
        • Western University of Health Sciences
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Illinois College of Optometry
    • New York
      • Jamaica, New York, United States, 11425
        • New York VA
      • New York, New York, United States, 10036
        • SUNY College of Optometry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects without eye disease

Description

Inclusion Criteria for Normal Group

  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. lOP <= 21 mmHg bilaterally
  5. BCVA 20/40 or better (each eye)
  6. Both eyes must be free of eye disease

Exclusion Criteria for Normal Group

  1. Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
  2. Subjects unable to tolerate ophthalmic imaging
  3. Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  4. HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives> 33%, or false negatives> 33%

  5. Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two findings:

    • On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level;
    • Glaucoma hemi-field test "outside normal limits."
  6. Presence of any ocular pathology except for cataract
  7. Narrow angle
  8. History of leukemia, dementia or multiple sclerosis
  9. Concomitant use of hydroxychloroquine and chloroquine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Normal Eyes
Subjects with no known ocular diseases will be scanned with the Maestro device
Device: 3D OCT-1 Maestro
OCT machines used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Retinal Thickness
Time Frame: 1 minute
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Topcon Medical Systems, Inc.

Investigators

  • Study Chair: Charles Reisman, MS, Topcon Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 12, 2015

First Submitted That Met QC Criteria

May 13, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Actual)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 6, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Maestro_NDB_II

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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