Age-Related Macular Degeneration (AMD) - Usability Study | NCT00963339

Studies
Age-Related Macular Degeneration (AMD) - Usability Study

NCT00963339

Sponsor

Notal Vision Ltd.

Status

Completed

Last Update Posted

Sep 23, 2010Estimated

Enrollment

54Actual

Phase

Not provided

Conditions

Age Related Macular Degeneration

Interventions

Foresee Home

Countries

Not provided

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

Sep 2010

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

Sep 2009

Primary Completion Date

Dec 2009Actual

Completion Date

Sep 2010Actual

First Submitted Date

Aug 20, 2009

First Submission Date that Met QC Criteria

Aug 20, 2009

First Posted Date

Aug 21, 2009Estimated

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 22, 2010

Last Update Posted Date

Sep 23, 2010Estimated

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

The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.

Detailed Description

The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.

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

54Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dry AMD		subjects diagnosed as intermediate AMD in at least one eye	Device: Foresee Home

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Foresee Home	Device	Home Monitoring	Dry AMD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Successful unpacking and installation		3 months
Successful self tutorial performance		3 months
Ability of the subjects to operate the device as define by a successful test completion		3 months

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the success rate of the interactive tutorial as defined by a reliable test result.		3 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria

Subjects diagnosed as intermediate AMD in at least one eye
Visual Acuity (VA) with habitual correction <20/60 in the study eye
Qualified in the clinic to use the device
Ability to speak, read and understand instructions in English
Subjects with ability to comprehend and sign the informed consent/authorization

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
Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye

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

Intermediate AMD

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Daniel Roth, MD	Vitreos retina center - NJ	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided