HMP (Home Macular Perimeter) -Usability Trial - Tabular View

Tracking Information

First Received Date ^ICMJE

January 1, 2008

Last Updated Date

May 26, 2008

Start Date ^ICMJE

November 2007

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of subjects who successfully set up the device [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Proportion of subjects who successfully pass the training program (successful calibration module) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00592826 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects with reliable tests results [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

HMP (Home Macular Perimeter) -Usability Trial

Official Title ^ICMJE

Phase III Study of the Usability of the HMP Device

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Case Control, Prospective

Condition ^ICMJE

Age Related Macular Degeneration

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2008

Primary Completion Date

January 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00592826

Responsible Party

Osnat Ehrman - Clinical Manager, Notal Vision

Study ID Numbers ^ICMJE

T3, WIRB Pr. No.: 20071980

Study Sponsor ^ICMJE

Notal Vision Ltd

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Adam Mr Weinstein, MD

Kidney Health Center of Maryland

Information Provided By

Notal Vision Ltd

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP