NCT03783858

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
356

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2019

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

4 months

First QC Date

December 19, 2018

Last Update Submit

June 8, 2020

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Single

OTHER
Device: P200TE

Interventions

P200TEDEVICE

OCT images

Single

Eligibility Criteria

Age22 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Simon Browning Optometrist

Bedford, England, MK40 2SR, United Kingdom

Location

Barnard Levit Optometrists

London, England, NW11 7EL, United Kingdom

Location

London Vision Clinic

London, England, W1G 7LA, United Kingdom

Location

Queens University

Belfast, Northern Ireland, BT7 1NN, United Kingdom

Location

Cameron Optometry

Edinburgh, Scotland, EH3 6SW, United Kingdom

Location

Study Officials

  • Tunde Peto, PhD

    Queens University Belfast

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2018

First Posted

December 21, 2018

Study Start

May 30, 2019

Primary Completion

October 8, 2019

Study Completion

April 20, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

GB(5)