Usage of the Home Macular Perimeter (HMP)

Age Related Macular Degeneration Clinical Trial

— HMP  

Official title:

Usage of the Home Macular Perimeter (HMP) in Intermediate Age Related Macular Degeneration Patients Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00596388
• Other study ID #: HMP-PU1
• Secondary ID: 0197-07
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: May 14, 2013
• Start date: March 2008
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
Israel	Haemek Medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who manage to use the device as in a daily testing		6 month	No

External Links

•   sponsor site