HMP (Home Macular Perimeter) -Usability Trial

NCT ID: NCT00592826

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2008-01-31

Brief Summary

The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .

Detailed Description

Stage I:

• Receive a packed HMP device.
• Unpack the device and install it, using a set-up guide
• Use an interactive tutorial to learn the task
• Calibrate the sensitivity of the test

This stage will be completed within 1 to 5 visits, depending on personal progress rate.

Subjects who have successfully completed stage I will be recruited to stage II.

Those subjects will:

• Perform 3 tests , each test in a different day

Conditions

Age Related Macular Degeneration

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Age >50 years
• Familiar with computer usage
• Capable and willing to sign a consent form and participate in the study
• Ability to speak, read and understand instructions in English

Exclusion Criteria

• Subject already participating in another study.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Notal Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adam Mr Weinstein, MD

Role: PRINCIPAL_INVESTIGATOR

Kidney Health Center of Maryland

Other Identifiers

WIRB Pr. No.: 20071980

Identifier Type: -

Identifier Source: secondary_id

T3

Identifier Type: -

Identifier Source: org_study_id