HMP (Home Macular Perimeter) -Usability Trial

This study has been completed.
Sponsor:
Information provided by:
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT00592826
First received: January 1, 2008
Last updated: May 26, 2008
Last verified: May 2008

January 1, 2008
May 26, 2008
November 2007
January 2008   (final data collection date for primary outcome measure)
  • Proportion of subjects who successfully set up the device [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Proportion of subjects who successfully pass the training program (successful calibration module) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00592826 on ClinicalTrials.gov Archive Site
Proportion of subjects with reliable tests results [ Time Frame: 1 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HMP (Home Macular Perimeter) -Usability Trial
Phase III Study of the Usability of the HMP Device

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 .

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

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects will be recruited in community centers and clinics and will include up to 25 people aged >50 years (Age-related Macular Degeneration age group). The group will be heterogeneous in terms of education, age, ethnic background, and gender. The subjects will be enrolled in one site in the USA In order to get 20 completed subjects, and based of assumption of 25% attrition- 25 subjects will be recruited to the study

Age Related Macular Degeneration
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
January 2008
January 2008   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00592826
T3, WIRB Pr. No.: 20071980
Yes
Osnat Ehrman - Clinical Manager, Notal Vision
Notal Vision Ltd
Not Provided
Principal Investigator: Adam Mr Weinstein, MD Kidney Health Center of Maryland
Notal Vision Ltd
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP