Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT03783858
  4. Details
NCT03783858 Clinical Trial

Image Collection of Normal Eyes for Development of an EU RDB

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03783858
Other study ID # OPT1030
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 30, 2019
Est. completion date April 20, 2020

Study information
Verified date June 2020
Source Optos, PLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 356
Est. completion date April 20, 2020
Est. primary completion date October 8, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 22 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• P200TE
OCT images

Locations
Country Name City State
United Kingdom Simon Browning Optometrist Bedford England
United Kingdom Queens University Belfast Northern Ireland
United Kingdom Cameron Optometry Edinburgh Scotland
United Kingdom Barnard Levit Optometrists London England
United Kingdom London Vision Clinic London England

Sponsors (1)
Lead Sponsor Collaborator
Optos, PLC

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1