Usage of the Home Macular Perimeter (HMP)

This study is currently recruiting participants.

Verified by Notal Vision Ltd, April 2009

First Received: January 7, 2008 Last Updated: April 20, 2009 History of Changes

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00596388

Purpose

Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.

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:	Cohort, Prospective
Official Title:	Usage of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients Pilot Study

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:

Proportion of subjects who manage to use the device as in a daily testing [ Time Frame: 6 month ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	15
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Subjects diagnosed as intermediate AMD

Detailed Description:

The pilot study purpose is to demonstrate that the tutorial which is part of the device software, is giving sufficient training for the intended users.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

• Subjects diagnosed as intermediate AMD

Criteria

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 >50 years
VA with habitual correction >20/60 in the study eye
Ability to speak, read and understand instructions in Hebrew
Familiar with computer usage

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 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596388

Contacts

Contact: Osnat Ms Ehrman, MSc

972-3-6293763 ext 117

osnat@notalvision.com

Locations

Israel
Haemek Medical center	Recruiting
Afula, Israel
Contact: Yaron Mr Lang, MD 972-4-6494329

Sponsors and Collaborators

Notal Vision Ltd

Investigators

Principal Investigator:

Yaron Mr Lang, MD

Haemek Hospital

More Information

Additional Information:

sponsor site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	NotalVision ( Osnat Ehrman )
Study ID Numbers:	HMP-PU1, 0197-07
Study First Received:	January 7, 2008
Last Updated:	April 20, 2009
ClinicalTrials.gov Identifier:	NCT00596388 History of Changes
Health Authority:	Israel: Ministry of Health

Keywords provided by Notal Vision Ltd:

HMP, AMD, CNV, PHP, HPHP

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