Age Related Macular Degeneration
Conditions
Keywords
AMD
Brief summary
The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.
Detailed description
The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.
Interventions
DEVICEForesee Home
Home Monitoring
Sponsors
Notal Vision Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects diagnosed as intermediate AMD in at least one eye * Visual Acuity (VA) with habitual correction \<20/60 in the study eye * Qualified in the clinic to use the device * Ability to speak, read and understand instructions in English * Subjects with ability to comprehend and sign the informed consent/authorization
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 * Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful self tutorial performance | 3 months |
| Ability of the subjects to operate the device as define by a successful test completion | 3 months |
| Successful unpacking and installation | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate the success rate of the interactive tutorial as defined by a reliable test result. | 3 month |
Outcome results
None listed