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OpenTrials
Completed

NCT Number: NCT00592826

HMP (Home Macular Perimeter) -Usability Trial

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 .

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Proportion of subjects who successfully set up the device

    Time frame: 1 month

  2. Proportion of subjects who successfully pass the training program (successful calibration module)

    Time frame: 1 month

Secondary outcomes

  1. Proportion of subjects with reliable tests results

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Official study title

Phase III Study of the Usability of the HMP Device

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jan 14, 2008
Registry last updated
Apr 14, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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