HMP (Home Macular Perimeter) -Usability Trial - Full Text View

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00592826

Purpose

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 .

Condition
Age Related Macular Degeneration

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Phase III Study of the Usability of the HMP Device

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	25
Study Start Date:	November 2007
Study Completion Date:	January 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects will be recruited in community centers and clinics and will include up to 25 people aged >50 years (Age-related Macular Degeneration age group). The group will be heterogeneous in terms of education, age, ethnic background, and gender. The subjects will be enrolled in one site in the USA In order to get 20 completed subjects, and based of assumption of 25% attrition- 25 subjects will be recruited to the study

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592826

Sponsors and Collaborators

Notal Vision Ltd

Investigators

Principal Investigator:

Adam Mr Weinstein, MD

Kidney Health Center of Maryland

More Information

No publications provided

Responsible Party:	Notal Vision ( Osnat Ehrman - Clinical Manager )
Study ID Numbers:	T3, WIRB Pr. No.: 20071980
Study First Received:	January 1, 2008
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00592826 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:

PHP
HMP
HPHP
AMD
CNV

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

Additional relevant MeSH terms:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009