Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients (UU2)

May 14, 2013 updated by: Notal Vision Ltd.

Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients

The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.

Study Overview

Status

Completed

Conditions

Detailed Description

Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.

Study Type

Observational

Enrollment (Actual)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar Saba, Israel
        • Meir Medical Center
      • Rechovot, Israel
        • Kaplan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects diagnosed as Intermediate AMD

Description

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 (in case a patient will convert during the study period he will be excluded)
    • Age more than 50 years
    • VA with habitual correction better than 20/60 in the study eye
    • Ability to speak, read and understand instructions in English or 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
    • Never been tested on the PHP device
    • Participation in another study with the exclusion of AREDS study
    • Patients diagnosed with geographic atrophy (GA)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Self trained subjects
2
supervised trained subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of subjects who managed to set the device
Time Frame: 6 months
6 months
Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training
Time Frame: 6 month
6 month
Number of device malfunctions
Time Frame: 6 month
6 month
Average use of the device
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Notal Vision Ltd.

Investigators

  • Principal Investigator: Haya Morori Katz, M.D., Kaplan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

September 4, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HMP-UU2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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