Image Collection of Normal Eyes for Development of an EU RDB

Image Collection of Normal Eyes on the Optos P200TE for Development of an EU Reference Database

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Device: P200TE

• Study Type: Interventional
• Enrollment (Actual): 356
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Bedford, England, United Kingdom, MK40 2SR
      • Simon Browning Optometrist
    • London, England, United Kingdom, W1G 7LA
      • London Vision Clinic
    • London, England, United Kingdom, NW11 7EL
      • Barnard Levit Optometrists
  • Northern Ireland
    • Belfast, Northern Ireland, United Kingdom, BT7 1NN
      • Queens University
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH3 6SW
      • Cameron Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single	Device: P200TE; OCT images

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retinal thickness	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.	1 day

Collaborators and Investigators

• Sponsor: Optos, PLC
• Investigators: Principal Investigator: Tunde Peto, PhD, Queens University Belfast

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2019
• Primary Completion (Actual): October 8, 2019
• Study Completion (Actual): April 20, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 19, 2018
• First Posted (Actual): December 21, 2018

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: OPT1030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No