Optos P200TE US Reference Database Study

Optos, PLC8 sites in 1 country800 target enrollmentMarch 14, 2023

ConditionsNormal Eyes

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Normal Eyes
Sponsor: Optos, PLC
Enrollment: 800
Locations: 8
Primary Endpoint: Optic Nerve Head
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to collect Optical Coherence Tomography (OCT) data to construct a reference database for the P200TE.

Detailed Description

The objective of this study is to collect Optical Coherence Tomography (OCT) data on healthy eyes in order to develop a reference database for the P200TE device in order to determine the reference limits for the P200TE

Registry

clinicaltrials.gov

Start Date

March 14, 2023

End Date

May 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Optos, PLC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects 22 years of age or older on the date of informed consent
•Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
•Subjects presenting at the site with normal eyes (Cataracts, LASIK, PRK (photorefractive keratectomy), and peripheral pathology that does not affect the posterior pole region, for example lattice and peripheral drusen, are allowed.
•BCVA (best corrected visual acuity) 20/40 or better(each eye)
•Subject is able to comply with the study procedures

Exclusion Criteria

•Subjects unable to tolerate ophthalmic imaging
•Subject has a condition or is in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
•Subject with ocular media not sufficiently clear toobtain acceptable OCT images
•.History of leukemia, dementia or multiple sclerosis