Healthy
Conditions
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
Interventions
DEVICEP200TE
OCT images
Sponsors
Optos, PLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subject 22 years of age or older on the date of informed consent 2. Subject able to understand the written informed consent and willing to participate as evidenced by signing the informed consent 3. Subject presenting at the site with normal eyes\* (Cataracts and LASIK and PRK are allowed) 4. BCVA 20/40 or better (each eye) 5. 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
1.1. Subject unable to tolerate ophthalmic imaging 2. Subject with ocular media not sufficiently clear to obtain acceptable OCT images 3. History of leukemia, dementia or multiple sclerosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retinal thickness | 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. |
Countries
United Kingdom
Outcome results
None listed