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

NCT00748384 — Completed, 30 participants, Notal Vision Ltd.

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

Registry	NCT00748384, acronym UU2
Status	Completed
Study type	Observational
Enrollment	30 (Actual)
Sponsor	Notal Vision Ltd. (Industry)
Conditions	Age Related Macular Degeneration
Dates	start 2009-02-01, primary completion 2013-03-01, completion 2013-05-01, first posted 2008-09-08, last updated 2013-05-15
Locations	2 sites in Israel

-Summary

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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+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.

+Arms and interventions

Arm	Type	Interventions	Description
1			Self trained subjects
2			supervised trained subjects

+Outcome measures

Primary outcomes

Proportion of subjects who managed to set the device [6 months]
Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training [6 month]
Number of device malfunctions [6 month]
Average use of the device [6 month]

+Eligibility

Sex: All, ages: 50 Years to any

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)

+Locations (2)

Facility	City	Country	Status
Meir Medical Center	Kfar Saba	Israel
Kaplan Medical Center	Rehovot	Israel

+Investigators

Haya Morori Katz, M.D., Principal investigator, Kaplan Medical Center