Triton Reference Database

NCT03067675 | Completed FDA Device

• 1 other identifier: Triton RDB
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 6

Brief Summary

The objective of this study is to collect OCT measurement data on normal healthy eyes.

Conditions

Healthy Eyes

Keywords

no known ocular pathology

Outcome Measures

Primary Outcomes (1)

• Retinal Thickness

  The thickness of the macula layer

  1 Minute

Study Arms (1)

Subjects Presenting With Normal Eyes

Subjects with no known ocular diseases will be scanned on the Topcon DRI OCT Triton (plus) device

Device: Topcon DRI OCT Triton (plus)

Interventions

Topcon DRI OCT Triton (plus) DEVICE

OCT Machine used for diagnostic purposes

Subjects Presenting With 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

The subject population will consist of 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 bilaterally (cataracts are acceptable)
• IOP ≤ 21 mmHg bilaterally
• BCVA 20/40 or better bilaterally

You may not qualify if:

• Subjects unable to tolerate ophthalmic imaging
• Subjects 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 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."
• Narrow angle
• History of leukemia, dementia or multiple sclerosis
• Concomitant use of hydroxychloroquine and chloroquine

Sponsors & Collaborators

• Topcon Corporation: lead

Study Sites (6)

Southern California College of Optometry

Anaheim, California, 92760, United States

Location

Accessoreyes Optometry

Pasadena, California, 91105, United States

Location

Illinois College of Optometry

Chicago, Illinois, 60616, United States

Location

Fischer Laser Eye Center

Willmar, Minnesota, 56201, United States

Location

New York VA

Jamaica, New York, 11425, United States

Location

Stat University of New York College of Optometry

New York, New York, 10036, United States

Location

Study Officials

• Charles Riesman, MS

  Topcon Corporation

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: March 1, 2017
• Primary Completion: August 30, 2017
• Study Completion: September 30, 2017
• Last Updated: June 8, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)