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

Crystalvue Medical Coporation1 site in 1 country285 target enrollmentSeptember 1, 2022

ConditionsHealthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Healthy
Sponsor: Crystalvue Medical Coporation
Enrollment: 285
Locations: 1
Primary Endpoint: The reference OCT data
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

September 1, 2022

End Date

October 31, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Crystalvue Medical Coporation

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.