Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients
UU2
1 other identifier
observational
30
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2009
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2008
CompletedFirst Posted
Study publicly available on registry
September 8, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 15, 2013
May 1, 2013
4.1 years
September 4, 2008
May 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
1
Self trained subjects
2
supervised trained subjects
Eligibility Criteria
Subjects diagnosed as Intermediate AMD
You may qualify if:
- 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
You may not qualify if:
- 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
- Patients diagnosed with geographic atrophy (GA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Meir Medical Center
Kfar Saba, Israel
Kaplan Medical Center
Rehovot, Israel
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haya Morori Katz, M.D.
Kaplan Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 4, 2008
First Posted
September 8, 2008
Study Start
February 1, 2009
Primary Completion
March 1, 2013
Study Completion
May 1, 2013
Last Updated
May 15, 2013
Record last verified: 2013-05