NCT03783858CompletedNot Applicable
Image Collection of Normal Eyes on the Optos P200TE for Development of an EU Reference Database
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Optos, PLC
- Enrollment
- 356
- Locations
- 5
- Primary Endpoint
- Retinal thickness
Study Overview
Brief Summary
This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject 22 years of age or older on the date of informed consent
- •Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
- •Subject presenting at the site with normal eyes* (Cataracts and LASIK and PRK are allowed)
- •BCVA 20/40 or better (each eye)
- •Subject is able to comply with the study procedures in the view of the investigator *Normal eyes are defined as eyes judged normal for the subjects age as determined by the PI or sub-investigator
Exclusion Criteria
- •Subject unable to tolerate ophthalmic imaging
- •Subject with ocular media not sufficiently clear to obtain acceptable OCT images
- •History of leukemia, dementia or multiple sclerosis
Arms & Interventions
Single
Other
Intervention: P200TE (Device)
Outcomes
Primary Outcomes
Retinal thickness
Time Frame: 1 day
In general, descriptive statistics (n, mean, standard deviation, median, minimum and maximum) and 95% confidence interval for the mean will be used to summarize each scan parameters. The 1st, 5th, 95th and 99th percentile results will be tabulated. All percentile results will be incorporated in the device software.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (5)
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