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

• Sponsor: Notal Vision Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00603850
• Collaborator: (none)
• Enrollment: 25
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 8.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration	Device: ForeseeHome

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
• Actual Enrollment: 25 participants
• 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
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Apr 1, 2008
• Actual Study Completion Date: Apr 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
1 Intermediate AMD Patients	Device: ForeseeHome; human factor

Outcome Measures

Primary Outcome Measures

1. Proportion of subjects who manage to use the device as in a daily testing [1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Sponsor web Site

Publications

None provided.

• Responsible Party: Notal Vision Ltd.
• ClinicalTrials.gov Identifier: NCT00603850
• Other Study ID Numbers: HMP-PU3; W121937330
• First Posted: Jan 29, 2008
• Last Update Posted: Apr 14, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by Notal Vision Ltd.: HMP, PHP, AMD, CNV, HPHP
• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Apr 14, 2015