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Completed

NCT Number: NCT06511440

Assessment of an Automated Optical Coherence Tomography and Camera : Reference Database

The objective of this study is to establish the Reference database of Vision-700.

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Key information

Conditions

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tri-Services General Hospital

Taipei County, Taiwan

About this study

The objective is to collect and establish the Reference database of Vision-700, which is expected to recruit subjects with normal vision to collect the optical coherent tomography measurement data.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects 22 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
  • 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."
  • History of leukemia, dementia or multiple sclerosis.
  • History of hydroxychloroquine or chloroquine use.
  • Subjects with photosensitivity.
  • Subject having Photodynamic therapy (PDT) within 6 months.
  • Subjects taking photosensitivity drug currently.

Treatment and study plan

Vision-700

Device

OCT machines used for diagnostic purposes

Primary outcomes

  1. The reference OCT data

    Time frame: 2022/09/01

    The study is to collect OCT measurement data on normal healthy eyes in order to establish the reference data range for OCT parameters, included full retinal thickness (μm), retinal nerve fiber layer (μm), ganglion cell complex thickness (μm) and optic nerve head (μm). The reference data range will provide it with the doctor to dignoisis.

Sponsors and collaborators

Lead sponsor

Crystalvue Medical Coporation

Industry

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 22, 2024
Registry last updated
Jul 22, 2024

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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