Usability of the PreView PHP for Home Use in Intermediate AMD Patients

Age Related Macular Degeneration Clinical Trial

Official title:

Usability of the PreView PHP for Home Use in Intermediate Age Related Macular Degeneration Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776451
• Other study ID #: PHP-US-01
• Status: Completed
• Phase: N/A
• First received: October 20, 2008
• Last updated: June 2, 2009
• Start date: November 2008
• Est. completion date: March 2009

Study information

• Verified date: June 2009
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.

Description:

The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 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 =65 years

• VA with habitual correction better than 20/60 in the study eye

• Ability to speak, read and understand instructions in English or Hebrew

• Qualified to use the device by health care professional

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 or macular 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: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
Israel	Belinson Medical Center	Petach Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of subjects who successfully completed the test by themselves, in a home simulated environment		2 clinic visits	No

External Links

•   sponsor web site