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Age-Related Macular Degeneration (AMD) - Usability Study

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00963339
First received: August 20, 2009
Last updated: September 22, 2010
Last verified: September 2010
History of Changes
  Purpose

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


Condition Intervention
Age Related Macular Degeneration
 Device: Foresee Home

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Age-Related Macular Degeneration (AMD) - Usability Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • Successful unpacking and installation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Successful self tutorial performance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ability of the subjects to operate the device as define by a successful test completion [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the success rate of the interactive tutorial as defined by a reliable test result. [ Time Frame: 3 month ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: September 2009
Study Completion Date: September 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Dry AMD
subjects diagnosed as intermediate AMD in at least one eye
 Device: Foresee Home
Home Monitoring

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Intermediate AMD

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963339

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

No publications provided

Responsible Party: Osnat Ehrman/Clinical manager, Notal Vision
ClinicalTrials.gov Identifier: NCT00963339     History of Changes
Other Study ID Numbers: US02
Study First Received: August 20, 2009
Last Updated: September 22, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:
AMD

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

ClinicalTrials.gov processed this record on May 19, 2013