Comparison of OCT and OCTA-based Ocular Measurements to T... | NCT03852485

Studies
Comparison of OCT and OCTA-based Ocular Measurements to Those of Predicate

NCT03852485

Sponsor

Optovue

Status

Completed

Last Update Posted

Sep 3, 2019Actual

Enrollment

199Actual

Phase

Not provided

Conditions

Normal Eyes and Eyes With Ocular Pathologies

Interventions

SD-OCT

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

Aug 2019

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 29, 2019Actual

Primary Completion Date

Aug 2, 2019Actual

Completion Date

Aug 30, 2019Actual

First Submitted Date

Feb 21, 2019

First Submission Date that Met QC Criteria

Feb 21, 2019

First Posted Date

Feb 25, 2019Actual

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

Aug 30, 2019

Last Update Posted Date

Sep 3, 2019Actual

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

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Comparison of OCT and OCTA-based Ocular Measurements to those of Predicate

Detailed Description

The purpose of this study is to compare with predicate device for the measurements of vascular structures and anatomical structures of the posterior pole of the eye based on OCTA and OCT scans in normal subjects, glaucoma patients, and retina patients, and to compare with predicate device for the measurements of corneal layers based on corneal OCT scans in normal subjects and cornea patients.

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

199Actual

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Normal	no glaucoma or retinal pathology or corneal conditions	Device: SD-OCT
Glaucoma	diagnosis of glaucoma	Device: SD-OCT
Retina	diagnosis of AMD, DR or other retinal pathology	Device: SD-OCT
Cornea	wear contact lens or prior refractive surgery or having dry eye or KCN	Device: SD-OCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SD-OCT	Device	Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures	Cornea Glaucoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Limits of agreement	estimation of the interval within which a proportion of the differences between measurements lie	Day 1

Secondary Outcomes

Measure	Description	Time Frame
Regression Analysis	statistical process for estimating the relationships among variables	Day 1

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

IInclusion Criteria:

Normal - No glaucoma or treatment to lower IOP or retinal pathology for posterior imaging; No contact lens wear, dry eye, anterior pathology or ocular surgery for corneal imaging.
Glaucoma - Have glaucoma and no history of other retinal pathology.
Retina - Have retinal pathology and no history of glaucoma or treatment to lower IOP.
Cornea - Contact lens wear or corneal condition such as dry eye, KCN, or post refractive surgery.

Exclusion Criteria:

Normal - Unable to complete required exams; Clinical finding of posterior pathology or VA worse than 20/40 for posterior imaging; Clinical findings of corneal condition for corneal imaging.
Glaucoma - Unable to complete required exams; Clinical signs of retinal pathology.
Retina - Unable to complete required exams.
Cornea - 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 care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IOVS		Newark	New Jersey	07103	United States
AMA

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