Healthy
Conditions
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.
Interventions
DEVICEVision-700
OCT machines used for diagnostic purposes
Sponsors
Crystalvue Medical Coporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Taiwan
Outcome results
None listed