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

June 2, 2009 updated by: Notal Vision Ltd.

Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients

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.

Study Overview

Status

Completed

Conditions

Age Related Macular Degeneration

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.

Study Type

Observational

Enrollment (Anticipated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Israel
- - Petach Tikva, Israel
    - Belinson Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Dry AMD subjects

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
1 Subjects diagnosed with Dry AMD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of subjects who successfully completed the test by themselves, in a home simulated environment Time Frame: 2 clinic visits	2 clinic visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Notal Vision Ltd.

Investigators

Principal Investigator: Neil Bressler, Prof., JHMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Sponsor web Site

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2008

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria