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Completed

NCT Number: NCT00963339

Age-Related Macular Degeneration (AMD) - Usability Study

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

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Foresee Home

Device

Home Monitoring

Primary outcomes

  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 outcomes

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

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Acronym: AMD

Important dates

Study start
2009
Primary completion
2009
Study completion
2010
First posted
Aug 21, 2009
Registry last updated
Sep 23, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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