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OpenTrials
Completed

NCT Number: NCT03783858

Image Collection of Normal Eyes for Development of an EU RDB

This study is designed to collect in-tissue OCT scans on the Optos P200TE on normal healthy eyes to develop a EU reference database

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Key information

Conditions

Healthy

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Simon Browning Optometrist, Bedford, England, United Kingdom

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

P200TE

Device

OCT images

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Optos, PLC

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Dec 21, 2018
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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