Testing the Effectiveness of the Interactive Tutorial of... | NCT00603850

Studies
Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP)

NCT00603850

Sponsor

Notal Vision Ltd.

Status

Completed

Last Update Posted

Apr 14, 2015Estimated

Enrollment

25Actual

Phase

Not provided

Conditions

Age Related Macular Degeneration

Interventions

ForeseeHome

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

ID	Type	Description	Link
W121937330

Status Module

Record Verification Date

Apr 2015

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 2008

Primary Completion Date

Apr 2008Actual

Completion Date

Apr 2008Actual

First Submitted Date

Jan 8, 2008

First Submission Date that Met QC Criteria

Jan 16, 2008

First Posted Date

Jan 29, 2008Estimated

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 13, 2015

Last Update Posted Date

Apr 14, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.

Detailed Description

The pilot study purpose is to demonstrate that the tutorial which is a part of the device software, is giving sufficient training for the intended users.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Intermediate AMD Patients	Device: ForeseeHome

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ForeseeHome	Device	human factor	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of subjects who manage to use the device as in a daily testing		1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Capable and willing to sign a consent form and participate in the study
Subjects diagnosed as intermediate AMD in at least one eye
Age >50 years
VA with habitual correction >20/60 in the study eye
Ability to speak, read and understand instructions in Hebrew
Familiar with computer usage

Exclusion Criteria:

Evidence of macular disease other than AMD or glaucoma in the study eye
Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP.
Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
Participation in another study with the exclusion of AREDS study
Patients diagnosed with geographic atrophy (GA)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects diagnosed as intermediate AMD in at least one eye

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Justin Mr Brown, MD	Charlotte Eye Ear Nose & Throat	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charlotte Eye Ear Nose & Throat		Charlotte	North Carolina	28210	United States

Label	URL
Sponsor web Site	View source

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid Diseases

Browse Leaves

Not provided

Browse Branches

Not provided