Age-Related Macular Degeneration (AMD) - Usability Study

Notal Vision Ltd.54 enrolled

Overview

The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Age Related Macular Degeneration

Interventions

Foresee HomeDEVICE

Home Monitoring

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Successful unpacking and installation

Time frame: 3 months

Successful self tutorial performance

Time frame: 3 months

Ability of the subjects to operate the device as define by a successful test completion

Time frame: 3 months

Secondary Outcomes

Evaluate the success rate of the interactive tutorial as defined by a reliable test result.

Time frame: 3 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.