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HMP (Home Macular Perimeter) -Usability Trial

Phase III Study of the Usability of the HMP Device

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00592826
Enrollment
25
Registered
2008-01-14
Start date
2007-11-30
Completion date
2008-01-31
Last updated
2015-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Keywords

PHP, HMP, HPHP, AMD, CNV

Brief 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 .

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

Interventions

None listed

Sponsors

Notal Vision Ltd.
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Proportion of subjects who successfully set up the device1 month
Proportion of subjects who successfully pass the training program (successful calibration module)1 month

Secondary

MeasureTime frame
Proportion of subjects with reliable tests results1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026