Image Collection of Normal Eyes for Development of an EU RDB | NCT03783858

Studies
Image Collection of Normal Eyes for Development of an EU RDB

NCT03783858

Sponsor

Optos, PLC

Status

Completed

Last Update Posted

Jun 9, 2020Actual

Enrollment

356Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

P200TE

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2019Actual

Primary Completion Date

Oct 8, 2019Actual

Completion Date

Apr 20, 2020Actual

First Submitted Date

Dec 19, 2018

First Submission Date that Met QC Criteria

Dec 19, 2018

First Posted Date

Dec 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2020

Last Update Posted Date

Jun 9, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

356Actual

Label	Type	Description	Intervention Names
Single	Other		Device: P200TE

Name	Type	Description	Arm Group Labels	Other Names
P200TE	Device	OCT images	Single

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tunde Peto, PhD	Queens University Belfast	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Simon Browning Optometrist		Bedford	England	MK40 2SR	United Kingdom
Barnard Levit Optometrists

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided