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Completed

NCT Number: NCT03067675

Triton Reference Database

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Southern California College of Optometry, Anaheim, California, United States

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About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Topcon DRI OCT Triton (plus)

Device

OCT Machine used for diagnostic purposes

Primary outcomes

  1. Retinal Thickness

    Time frame: 1 Minute

    The thickness of the macula layer

Sponsors and collaborators

Lead sponsor

Topcon Corporation

Industry

Registry information

Official study title

Topcon DRI OCT Triton Reference Database Study

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 1, 2017
Registry last updated
Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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