Topcon 3D OCT-1 Maestro Reference Database Study II

NCT02447120 | Completed

• 1 other identifier: Maestro_NDB_II
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 7

Brief Summary

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%.

Conditions

Healthy

Keywords

Volunteers with Healthy Eyes

Outcome Measures

Primary Outcomes (1)

• Retinal Thickness

  1 minute

Study Arms (1)

Normal Eyes

Subjects with no known ocular diseases will be scanned with the Maestro device

Device: 3D OCT-1 Maestro

Interventions

3D OCT-1 Maestro DEVICE

OCT machines used for diagnostic purposes

Normal Eyes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects without eye disease

You may qualify if:

• Subjects 18 years of age or older on the date of informed consent
• Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
• Subjects presenting at the site with normal eyes (eyes without pathology)
• lOP \<= 21 mmHg bilaterally
• BCVA 20/40 or better (each eye)
• Both eyes must be free of eye disease

You may not qualify if:

• Subjects previously enrolled in either the Maestro AP study or the Maestro2 study
• Subjects unable to tolerate ophthalmic imaging
• Subject with ocular media not sufficiently clear to obtain acceptable OCT images
• 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%
• 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."
• Presence of any ocular pathology except for cataract
• Narrow angle
• History of leukemia, dementia or multiple sclerosis
• Concomitant use of hydroxychloroquine and chloroquine

Sponsors & Collaborators

• Topcon Medical Systems, Inc.: lead

Study Sites (7)

UAB School of Optometry

Birmingham, Alabama, 35233, United States

Location

Southern California College of Optometry

Fullerton, California, 92831, United States

Location

Valley Eyecare Center

Livermore, California, 94550, United States

Location

Western University of Health Sciences

Pomona, California, 91716, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

New York VA

Jamaica, New York, 11425, United States

Location

SUNY College of Optometry

New York, New York, 10036, United States

Location

Study Officials

• Charles Reisman, MS

  Topcon Corporation

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2015
• First Posted: May 18, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

US (7)