Status:
COMPLETED
Assessment of an Automated Optical Coherence Tomography and Camera : Reference Database
Lead Sponsor:
Crystalvue Medical Coporation
Conditions:
Healthy
Eligibility:
All Genders
22+ years
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.
Eligibility Criteria
Inclusion
- Subjects 22 years of age or older on the date of informed consent
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
285 Patients enrolled
Trial Details
Trial ID
NCT06511440
Start Date
September 1 2022
End Date
October 31 2023
Last Update
July 22 2024
Active Locations (1)
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1
Tri-Services General Hospital
Taipei County, Taiwan