Performance Evaluation of OCT and OCT Angiography-based O... | NCT04437082

Studies
Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography)

NCT04437082

Sponsor

Optovue

Status

Completed

Last Update Posted

Sep 20, 2021Actual

Enrollment

143Actual

Phase

Not provided

Conditions

Normal Eyes and Ocular Pathology

Interventions

optical coherence tomography

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

Feb 2021

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

Jan 15, 2021Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Apr 30, 2021Actual

First Submitted Date

Jun 15, 2020

First Submission Date that Met QC Criteria

Jun 17, 2020

First Posted Date

Jun 18, 2020Actual

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

Sep 13, 2021

Last Update Posted Date

Sep 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

143Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Normal	no pre-existing conditions	Device: optical coherence tomography
Glaucoma	diagnosis of glaucoma	Device: optical coherence tomography
Retina	diagnosis of retina pathology	Device: optical coherence tomography
Cornea	diagnosis of corneal condition	Device: optical coherence tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
optical coherence tomography	Device	imaging structural and vascular features of the eye	Cornea Glaucoma Normal Retina

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Standard Deviation	measure of variance	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Normal - No pre-existing conditions.
Glaucoma - Diagnosis of glaucoma.
Retina - Diagnosis of retinal pathology
Cornea - Diagnosis of clinic condition.

Exclusion Criteria:

- Unable to complete required exams.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Seeing eye doctor for routine or follow-up care

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oklahoma College of Optometry, Northeastern State University		Tahlequah	Oklahoma	74464	United States

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

Intervention Browse Module

MeSH Terms

ID	Term
D041623	Tomography, Optical Coherence

Ancestor Terms

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided