Usability of the PreView PHP for Home Use in Intermediate AMD Patients
1 other identifier
observational
66
1 country
1
Brief Summary
To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2008
Shorter than P25 for all trials
1 active site
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
October 20, 2008
CompletedFirst Posted
Study publicly available on registry
October 21, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJune 3, 2009
June 1, 2009
3 months
October 20, 2008
June 2, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of subjects who successfully completed the test by themselves, in a home simulated environment
2 clinic visits
Study Arms (1)
1
Subjects diagnosed with Dry AMD
Eligibility Criteria
Dry AMD subjects
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
- Age ≥65 years
- VA with habitual correction better than 20/60 in the study eye
- Ability to speak, read and understand instructions in English or Hebrew
- Qualified to use the device by health care professional
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 or macular surgery performed within 3 months prior to study entry in the target eye
- Patients diagnosed with geographic atrophy (GA)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Belinson Medical Center
Petah Tikva, Israel
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Neil Bressler, Prof.
JHMC
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 20, 2008
First Posted
October 21, 2008
Study Start
November 1, 2008
Primary Completion
February 1, 2009
Study Completion
March 1, 2009
Last Updated
June 3, 2009
Record last verified: 2009-06