P200TE US Reference Database Study | NCT05844852

Studies
P200TE US Reference Database Study

NCT05844852

Sponsor

Optos, PLC

Status

Unknown status

Last Update Posted

Apr 3, 2024Actual

Enrollment

800Estimated

Phase

Not Applicable

Conditions

Normal Eyes

Interventions

P200TE

Countries

United States

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

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 14, 2023Actual

Primary Completion Date

May 1, 2024Estimated

Completion Date

May 1, 2024Estimated

First Submitted Date

Mar 30, 2023

First Submission Date that Met QC Criteria

May 2, 2023

First Posted Date

May 6, 2023Actual

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

Apr 2, 2024

Last Update Posted Date

Apr 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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

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

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OCT	Other	Device: P200TE The P200TE provides OCT imaging including retina topography and ONH (optic nerve head) scans.	Device: P200TE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
P200TE	Device	The P200TE provides OCT imaging including retinatopography and ONH (optic nerve head) scans.	OCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Retinal Thickness	The full thickness retina grid consists of a 9-sector circular grid pattern centered on the fovea and based on the ETDRS criteria.	1 year
GCC Thickness	The GCC Thickness	1 year
RNFL Thickness	The RNFL thickness	1 year
Optic Nerve Head	The ONH size	1 year

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events	Number of any adverse events associated with the clinical study to ensure device safety.	1 year

Other Outcomes

Not provided

Eligibility Module

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

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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Marshall B Ketchum University, Southern California College of Optometry		Anaheim	California	92807	United States