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Clinical Trials/NCT00603850
NCT00603850CompletedNot Applicable

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

Notal Vision Ltd.1 site in 1 country25 target enrollmentStarted: January 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Proportion of subjects who manage to use the device as in a daily testing

Study Overview

Brief Summary

Demonstrate the ability of the current interactive tutorial and 1-800 support to teach an AMD patient to use the HMP device.

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Proportion of subjects who manage to use the device as in a daily testing

Time Frame: 1 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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