Usage of the Home Macular Perimeter (HMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00596388
First received: January 7, 2008
Last updated: May 14, 2013
Last verified: May 2013
  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 ] [ Designated as safety issue: No ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT00596388     History of Changes
Other Study ID Numbers: HMP-PU1, 0197-07
Study First Received: January 7, 2008
Last Updated: May 14, 2013
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on July 29, 2014