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

Completed

• Conditions: Healthy
• Interventions: Device: Vision-700

• Registration Number: NCT06511440
• Lead Sponsor: Crystalvue Medical Coporation

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.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-04
• Study First Submitted QC: 2024-07-18
• Last Update Submitted: 2024-07-18
• Study First Posted: 2024-07-22
• Last Update Posted: 2024-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 285

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy group	Vision-700	Subject without eye disease

Primary Outcome Measures

Name	Time	Method
The reference OCT data	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.

Trial Locations

Locations (1)

Tri-Services General Hospital; 🇨🇳 Taipei county, Taiwan