Age Related Macular Degeneration
Conditions
Keywords
AMD
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.
Detailed description
The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.
Interventions
None listed
Sponsors
Notal Vision Ltd.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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 * 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
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 or macular surgery performed within 3 months prior to study entry in the target eye * Participation in another study with the exclusion of AREDS study * Patients diagnosed with geographic atrophy (GA)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who successfully completed the test by themselves, in a home simulated environment | 2 clinic visits |
Countries
Israel
Outcome results
None listed