Triton Reference Database

Topcon DRI OCT Triton Reference Database Study

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

Study Overview

• Status: Completed
• Conditions: Healthy Eyes
• Intervention / Treatment: Device: Topcon DRI OCT Triton (plus)

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 DRI OCT Triton based on the percentile points for 1%, 5%, 95%, and 99%.

• Study Type: Observational
• Enrollment (Actual): 500

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92760
      • Southern California College of Optometry
    • Pasadena, California, United States, 91105
      • Accessoreyes Optometry
  • Illinois
    • Chicago, Illinois, United States, 60616
      • Illinois College of Optometry
  • Minnesota
    • Willmar, Minnesota, United States, 56201
      • Fischer Laser Eye Center
  • New York
    • Jamaica, New York, United States, 11425
      • New York VA
    • New York, New York, United States, 10036
      • Stat University of New York College of Optometry

Participation Criteria

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

The subject population will consist of subjects without eye disease.

Description

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 bilaterally (cataracts are acceptable)
4. IOP ≤ 21 mmHg bilaterally
5. BCVA 20/40 or better bilaterally

Exclusion Criteria

1. Subjects unable to tolerate ophthalmic imaging
2. Subjects with ocular media not sufficiently clear to obtain acceptable OCT images
3. 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%

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

   1. 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;
   2. Glaucoma hemi-field test "outside normal limits."
5. Narrow angle
6. History of leukemia, dementia or multiple sclerosis
7. Concomitant use of hydroxychloroquine and chloroquine

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); OCT Machine used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal Thickness	The thickness of the macula layer	1 Minute

Collaborators and Investigators

• Sponsor: Topcon Corporation
• Investigators: Study Chair: Charles Riesman, MS, Topcon Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): September 30, 2017

Study Registration Dates

• First Submitted: February 24, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

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: no known ocular pathology
• Other Study ID Numbers: Triton RDB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No