Macular Thickness Measurements Using Retinal-thickness OCT | NCT03030729

Studies
Macular Thickness Measurements Using Retinal-thickness OCT

NCT03030729

Sponsor

Notal Vision Ltd.

Status

Completed

Last Update Posted

Jun 17, 2019Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Age-Related Macular Degeneration
Diabetic Retinopathy

Interventions

Not provided

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

Jan 2017

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

Mar 14, 2017Actual

Primary Completion Date

Jan 14, 2018Actual

Completion Date

Jan 14, 2018Actual

First Submitted Date

Jan 23, 2017

First Submission Date that Met QC Criteria

Jan 24, 2017

First Posted Date

Jan 25, 2017Estimated

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

Jun 13, 2019

Last Update Posted Date

Jun 17, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Comparison between retinal measurements, done by the RT (Retinal Thickness) imaging and a commercial OCT (Optical Coherence Tomography)

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

14Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison between retinal measurements, done by the RTOCT device and a commercial OCT		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability and agreement to give informed consent (IC)
Diagnosis of AMD or DR in SE by OCT
Ability to undergo OCT scans

Exclusion Criteria:

AMD and DR in the same SE
Evidence of macular disease other than AMD or DME in SE

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

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sorasky Medical Center		Tel Aviv			Israel

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Intermediate AMD
Advanced AMD
DR without macular edema
DR with macular edema