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

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. Identifier: NCT00963339
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : September 23, 2010
Information provided by:
Notal Vision Ltd

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

Condition or disease Intervention/treatment
Age Related Macular Degeneration Device: Foresee Home

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.

Study Type : Observational
Actual Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Age-Related Macular Degeneration (AMD) - Usability Study
Study Start Date : September 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
subjects diagnosed as intermediate AMD in at least one eye
Device: Foresee Home
Home Monitoring

Primary Outcome Measures :
  1. Successful unpacking and installation [ Time Frame: 3 months ]
  2. Successful self tutorial performance [ Time Frame: 3 months ]
  3. Ability of the subjects to operate the device as define by a successful test completion [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Evaluate the success rate of the interactive tutorial as defined by a reliable test result. [ Time Frame: 3 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intermediate AMD

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

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 identifier (NCT number): NCT00963339

Sponsors and Collaborators
Notal Vision Ltd
Principal Investigator: Daniel Roth, MD Vitreos retina center - NJ

Responsible Party: Osnat Ehrman/Clinical manager, Notal Vision Identifier: NCT00963339     History of Changes
Other Study ID Numbers: US02
First Posted: August 21, 2009    Key Record Dates
Last Update Posted: September 23, 2010
Last Verified: September 2010

Keywords provided by Notal Vision Ltd:

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