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
  Purpose

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 .


Condition
Age Related Macular Degeneration

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Phase III Study of the Usability of the HMP Device

Resource links provided by NLM:


Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Proportion of subjects with reliable tests results [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 25
Study Start Date: November 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Detailed 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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592826

Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Adam Mr Weinstein, MD Kidney Health Center of Maryland
  More Information

No publications provided

Responsible Party: Osnat Ehrman - Clinical Manager, Notal Vision
ClinicalTrials.gov Identifier: NCT00592826     History of Changes
Other Study ID Numbers: T3, WIRB Pr. No.: 20071980
Study First Received: January 1, 2008
Last Updated: May 26, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Notal Vision Ltd:
PHP
HMP
HPHP
AMD
CNV

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on September 30, 2014