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
  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:


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
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: 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:
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 October 19, 2014