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CompletedNCT06511440Updated Jul 22, 2024

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

An observational study in Healthy, sponsored by Crystalvue Medical Coporation. Completed at 1 site in Taiwan. Open to participants aged 22 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-22.

Sponsored by Crystalvue Medical Coporation · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
285
Ages
22 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Crystalvue Medical Coporation is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy subjects

Inclusion criteria

  1. Subjects 22 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
  4. IOP ≤ 21 mmHg bilaterally
  5. BCVA 20/40 or better bilaterally

Exclusion criteria

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: 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."
  5. History of leukemia, dementia or multiple sclerosis.
  6. History of hydroxychloroquine or chloroquine use.
  7. Subjects with photosensitivity.
  8. Subject having Photodynamic therapy (PDT) within 6 months.
  9. Subjects taking photosensitivity drug currently.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
285 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy group

    Subject without eye disease

    Device: Vision-700

Interventions

  • DeviceVision-700

    OCT machines used for diagnostic purposes

06

What researchers measure

Primary outcomes

  1. The reference OCT data

    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.

    Time frame: 2022/09/01

07

Study locations

1 site
  • Tri-Services General Hospital
    Taipei county, Taiwan
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06511440
Lead sponsor
Crystalvue Medical Coporation
Responsible party
Sponsor
First posted
Jul 22, 2024
Start date
Sep 1, 2022
Primary completion
Oct 31, 2023
Completion
Oct 31, 2023
Last update
Jul 22, 2024

Study contacts

Liang I-Chia
principal investigator · Tri-Services General Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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