NCT06511440

Completed

Assessment of an Automated Optical Coherence Tomography and ...

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Other study identifiers

Sponsor study identifier

Vision-700 Reference database

Study Type

observational

Actual enrollment (reported)

285

Locations

1 country

Sites

1

Timeline

Study Start

September 1, 2022

Actual (reported)

Primary Completion

October 31, 2023

Actual (reported)

Study Completion

October 31, 2023

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 285 participants
Study completion date: October 31, 2023
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
September 1, 2022
Actual (reported)
Primary Completion
October 31, 2023
Actual (reported)
Study Completion
October 31, 2023
Actual (reported)
First Submitted
July 4, 2024
Actual (reported)
First Posted
July 22, 2024
Actual (reported)

Last Updated: July 22, 2024
Status Verified: July 2024
Last Update Submitted: July 18, 2024

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-700Device

OCT machines used for diagnostic purposes

Healthy group

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age22 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Healthy subjects

You may qualify if:

Subjects 22 years of age or older on the date of informed consent

Sponsors & Collaborators

Crystalvue Medical Coporation
Industrylead

Study Sites (1)

Tri-Services General Hospital

Taipei County, Taiwan

Study Officials

Liang I-Chia
Tri-Services General Hospital
PRINCIPAL INVESTIGATOR

Enrollment

285 participants (actual enrollment reported by the registry).

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

Actual (reported)

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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.

Contact the study team to confirm eligibility.

Primary Completion

October 31, 2023

Actual (reported)

Study Completion

October 31, 2023

Actual (reported)

Last Updated

July 22, 2024

Record last verified: 2024-07

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT06511440
Data provider: ClinicalTrials.gov
Source updated: 2024-07-22
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:21:19 UTC

Locations

TW(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Healthy group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations