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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

285 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy group

Subject without eye disease

Vision-700

Intervention Type DEVICE

OCT machines used for diagnostic purposes

Interventions

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Vision-700

OCT machines used for diagnostic purposes

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes