Image Collection of Normal Eyes for Development of an EU RDB

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: P200TE

• Registration Number: NCT03783858
• Lead Sponsor: Optos, PLC

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-19
• Study First Posted: 2018-12-21
• Study Start: 2019-05-30
• Primary Completion: 2019-10-08
• Study Completion: 2020-04-20
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-08
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single	P200TE	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (5)

Queens University; 🇬🇧 Belfast, Northern Ireland, United Kingdom

Cameron Optometry; 🇬🇧 Edinburgh, Scotland, United Kingdom

Simon Browning Optometrist; 🇬🇧 Bedford, England, United Kingdom

London Vision Clinic; 🇬🇧 London, England, United Kingdom

Barnard Levit Optometrists; 🇬🇧 London, England, United Kingdom