Age-Related Macular Degeneration (AMD) - Usability Study

Notal Vision

Status: Completed

Conditions: Age Related Macular Degeneration

Treatments: Device: Foresee Home

Study type: Observational

Funder types: Industry

Identifiers

NCT00963339

US02

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

54 participants in 1 patient group

Dry AMD

Description:

subjects diagnosed as intermediate AMD in at least one eye

Treatment:

Device: Foresee Home