Usability of the PreView PHP for Home Use in Intermediate AMD Patients

Notal Vision

Status: Completed

Conditions: Age Related Macular Degeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT00776451

PHP-US-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

66 participants in 1 patient group

1

Description:

Subjects diagnosed with Dry AMD