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Completed

NCT Number: NCT00748384

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

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Key information

Conditions

Age Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Meir Medical Center, Kfar Saba, Israel

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Primary outcomes

  1. Proportion of subjects who managed to set the device

    Time frame: 6 months

  2. Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training

    Time frame: 6 month

  3. Number of device malfunctions

    Time frame: 6 month

  4. Average use of the device

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Official study title

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

Acronym: UU2

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 8, 2008
Registry last updated
May 15, 2013

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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