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Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP)

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00603850
First received: January 8, 2008
Last updated: May 26, 2008
Last verified: May 2008
History of Changes
  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: Testing the Effectiveness of the Interactive Tutorial of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients

Resource links provided by NLM:

U.S. FDA Resources

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 ]

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

Additional Information:
Sponsor web Site  This link exits the ClinicalTrials.gov site

No publications provided

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

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

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

ClinicalTrials.gov processed this record on May 19, 2013