Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP) - Full Text View

Sponsored by:	Notal Vision Ltd
Information provided by:	Notal Vision Ltd
ClinicalTrials.gov Identifier:	NCT00603850

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:	Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients

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: 1 month ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

Groups/Cohorts
1 Intermediate AMD Patients

Detailed Description:

The pilot study purpose is to demonstrate that the tutorial which is a 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 in at least one eye

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: NCT00603850

Locations

United States, North Carolina
Charlotte Eye Ear Nose & Throat
Charlotte, North Carolina, United States, 28210

Sponsors and Collaborators

Notal Vision Ltd

Investigators

Principal Investigator:

Justin Mr Brown, MD

Charlotte Eye Ear Nose & Throat

More Information

Sponsor web Site This link exits the ClinicalTrials.gov site

Responsible Party:	NotalVision ( Osnat Ehrman )
Study ID Numbers:	HMP-PU3, W121937330
Study First Received:	January 8, 2008
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00603850
Health Authority:	United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:

HMP, PHP, AMD, CNV, HPHP

Study placed in the following topic categories:

Eye Diseases
Retinal Degeneration
Macular Degeneration
Retinal Diseases
Retinal degeneration

ClinicalTrials.gov processed this record on January 14, 2009