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Usage of the Home Macular Perimeter (HMP) (HMP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00596388
First Posted: January 17, 2008
Last Update Posted: May 15, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Notal Vision Ltd
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Usage of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients Pilot Study

Resource links provided by NLM:


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 ]

Enrollment: 20
Study Start Date: March 2008
Study Completion Date: March 2013
Primary Completion Date: January 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00596388


Locations
Israel
Haemek Medical center
Afula, Israel
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Yaron Mr Lang, MD Haemek Hospital
  More Information

Additional Information:
Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT00596388     History of Changes
Other Study ID Numbers: HMP-PU1
0197-07
First Submitted: January 7, 2008
First Posted: January 17, 2008
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by Notal Vision Ltd:
HMP, AMD, CNV, PHP, HPHP

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases