Retinal Imaging Using NOTAL-OCT V2.5 | NCT03600519

Studies
Retinal Imaging Using NOTAL-OCT V2.5

NCT03600519

Sponsor

Notal Vision Ltd.

Status

Completed

Last Update Posted

Nov 13, 2020Actual

Enrollment

87Actual

Phase

Not provided

Conditions

Interventions

NOTAL OCT V2.5

Countries

Israel

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

Oct 2020

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

Jul 22, 2018Actual

Primary Completion Date

Feb 18, 2019Actual

Completion Date

Jan 1, 2020Actual

First Submitted Date

Jul 17, 2018

First Submission Date that Met QC Criteria

Jul 17, 2018

First Posted Date

Jul 26, 2018Actual

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

Nov 11, 2020

Last Update Posted Date

Nov 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Primary objectives:

To compare between retinal measurements, done by the NOTAL-OCT V2.5 device and a commercial OCT.

Secondary objectives:

To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula.
To evaluate the repeatability of the NOTAL-OCT V2.5

Detailed Description

Study population:

AMD population - intermediate and advanced AMD (with active and nonactive CNV)
DR population. Patient with and without DME

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

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AMD Patients		OCT scan	Device: NOTAL OCT V2.5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NOTAL OCT V2.5	Device	AMD Patients	AMD Patients	OCT scan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The level of agreement between NOTAL-OCT V2.5 and commercial OCT in detecting fluid	measurements of retinal thickness.	less than an hour

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

a- Ability and agreement to give informed consent (IC) b -Diagnosis of AMD or DR in SE by OCT c- Ability to undergo OCT scans d- VA of 20/400 (6/120) or better in SE
Exclusion Criteria:
1. AMD and DR in the same SE
2. Evidence of macular disease other than AMD or DME in SE
3. Patient with dilated eye(s)

Accepts Healthy Volunteers

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

MAD patients

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Bnei Zion		Haifa		3339123	Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided