Triton Reference Database

Topcon DRI OCT Triton Reference Database Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03067675

Enrollment

500

Registered

2017-03-01

Start date

2017-03-01

Completion date

2017-09-30

Last updated

2022-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Eyes

Keywords

no known ocular pathology

Brief summary

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

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%.

Interventions

DEVICETopcon DRI OCT Triton (plus)

OCT Machine used for diagnostic purposes

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026