Assessment of an Automated Optical Coherence Tomography a... | NCT06511440

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

NCT06511440

Sponsor

Crystalvue Medical Coporation

Status

Completed

Last Update Posted

Jul 22, 2024Actual

Enrollment

285Actual

Phase

Not provided

Conditions

Healthy

Interventions

Vision-700

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Oct 31, 2023Actual

Completion Date

Oct 31, 2023Actual

First Submitted Date

Jul 4, 2024

First Submission Date that Met QC Criteria

Jul 18, 2024

First Posted Date

Jul 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2024

Last Update Posted Date

Jul 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

285Actual

Label	Type	Description	Intervention Names
Healthy group		Subject without eye disease	Device: Vision-700

Name	Type	Description	Arm Group Labels	Other Names
Vision-700	Device	OCT machines used for diagnostic purposes	Healthy group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Liang I-Chia	Tri-Services General Hospital	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided