HMP (Home Macular Perimeter) -Usability Trial

Age Related Macular Degeneration Clinical Trial

Official title:

Phase III Study of the Usability of the HMP Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00592826
• Other study ID #: T3
• Secondary ID: WIRB Pr. No.: 20
• Status: Completed
• Phase: N/A
• First received: January 1, 2008
• Last updated: April 13, 2015
• Start date: November 2007
• Est. completion date: January 2008

Study information

• Verified date: April 2015
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The study is divided in two stages. The purpose of the first stage is to evaluate the percentage of subjects that can unpack the device, install it, learn the task and calibrate it according to their personal capabilities. The purpose of the second stage is to assess the ability of the subjects to perform reliable tests .

Description:

Stage I:

• Receive a packed HMP device.

• Unpack the device and install it, using a set-up guide

• Use an interactive tutorial to learn the task

• Calibrate the sensitivity of the test

This stage will be completed within 1 to 5 visits, depending on personal progress rate.

Subjects who have successfully completed stage I will be recruited to stage II.

Those subjects will:

• Perform 3 tests , each test in a different day

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Age >50 years

• Familiar with computer usage

• Capable and willing to sign a consent form and participate in the study

• Ability to speak, read and understand instructions in English

Exclusion Criteria:

• Subject already participating in another study.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who successfully set up the device		1 month	No
Primary	Proportion of subjects who successfully pass the training program (successful calibration module)		1 month	No
Secondary	Proportion of subjects with reliable tests results		1 month	No