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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: 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.

• Study Type: Observational
• Enrollment (Actual): 285

Contacts and Locations

Study Locations

• Taiwan
  • Taipei county, Taiwan
    • Tri-Services General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Healthy subjects

Description

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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy group; Subject without eye disease	Device: Vision-700; OCT machines used for diagnostic purposes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Crystalvue Medical Coporation
• Investigators: Principal Investigator: Liang I-Chia, Tri-Services General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 4, 2024
• First Submitted That Met QC Criteria: July 18, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Vision-700 Reference database

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No