NCT00963339

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2009

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

September 23, 2010

Status Verified

September 1, 2010

Enrollment Period

3 months

First QC Date

August 20, 2009

Last Update Submit

September 22, 2010

Conditions

Age Related Macular Degeneration

Keywords

AMD

Outcome Measures

Primary Outcomes (3)

  • 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 (1)

  • Evaluate the success rate of the interactive tutorial as defined by a reliable test result.

    3 month

Study Arms (1)

Dry AMD

subjects diagnosed as intermediate AMD in at least one eye

Device: Foresee Home

Interventions

Foresee HomeDEVICE

Home Monitoring

Dry AMD

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Intermediate AMD

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Daniel Roth, MD

    Vitreos retina center - NJ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 20, 2009

First Posted

August 21, 2009

Study Start

September 1, 2009

Primary Completion

December 1, 2009

Study Completion

September 1, 2010

Last Updated

September 23, 2010

Record last verified: 2010-09