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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00748384
First Posted: September 8, 2008
Last Update Posted: May 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Notal Vision Ltd
  Purpose
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.

Condition
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients

Resource links provided by NLM:


Further study details as provided by Notal Vision Ltd:

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

Enrollment: 30
Study Start Date: February 2009
Study Completion Date: May 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Self trained subjects
2
supervised trained subjects

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects diagnosed as Intermediate AMD
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 (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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00748384


Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Kaplan Medical Center
Rechovot, Israel
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Haya Morori Katz, M.D. Kaplan Medical Center
  More Information

Additional Information:
Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT00748384     History of Changes
Other Study ID Numbers: HMP-UU2
First Submitted: September 4, 2008
First Posted: September 8, 2008
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Notal Vision Ltd:
HMP, CNV, AMD, PHP, HPHP, foresee

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases