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

NCT06511440 | Completed DMC

• 1 other identifier: Vision-700 Reference database
• Study Type: observational
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

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.

  2022/09/01

Study Arms (1)

Healthy group

Subject without eye disease

Device: Vision-700

Interventions

Vision-700 DEVICE

OCT machines used for diagnostic purposes

Healthy group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Crystalvue Medical Coporation: lead

Study Sites (1)

Tri-Services General Hospital

Taipei County, Taiwan

Location

Study Officials

• Liang I-Chia

  Tri-Services General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2024
• First Posted: July 22, 2024
• Study Start: September 1, 2022
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: July 22, 2024

Record last verified: 2024-07

Locations

TW (1)