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CompletedNCT00963339AMDUpdated Sep 23, 2010

Age-Related Macular Degeneration (AMD) - Usability Study

An observational study in Age Related Macular Degeneration, sponsored by Notal Vision Ltd.. Completed. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2010-09-23.

Sponsored by Notal Vision Ltd. · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
54
Ages
50 Years and older
Sex
All
01

Study summary

The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.

Read the detailed description

The AMD usability study is a prospective, longitudinal, multi-center, observational study of patients diagnosed with intermediate (dry) AMD who have been asked by their doctor to use the ForeseeHomeTM device to record the natural progression of their AMD, including conversion from the dry to wet stage.

02

Conditions studied

  • Age Related Macular Degeneration

Keywords

  • AMD
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 54 is below the median of 106 across 421 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Notal Vision Ltd. is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Intermediate AMD

Inclusion criteria

  • Subjects diagnosed as intermediate AMD in at least one eye
  • Visual Acuity (VA) with habitual correction \<20/60 in the study eye
  • Qualified in the clinic to use the device
  • Ability to speak, read and understand instructions in English
  • Subjects with ability to comprehend and sign the informed consent/authorization

Exclusion criteria

Exclusion criteria

  • Evidence of macular disease other than AMD or glaucoma in the study eye
  • Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
54 participants (actual)

Groups and cohorts

  • Dry AMD

    subjects diagnosed as intermediate AMD in at least one eye

    Device: Foresee Home

Interventions

  • DeviceForesee Home

    Home Monitoring

06

What researchers measure

Primary outcomes

  1. Successful unpacking and installation

    Time frame: 3 months

  2. Successful self tutorial performance

    Time frame: 3 months

  3. Ability of the subjects to operate the device as define by a successful test completion

    Time frame: 3 months

Secondary outcomes

  1. Evaluate the success rate of the interactive tutorial as defined by a reliable test result.

    Time frame: 3 month

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00963339
Lead sponsor
Notal Vision Ltd.
First posted
Aug 21, 2009
Start date
Sep 2009
Primary completion
Dec 2009
Completion
Sep 2010
Last update
Sep 23, 2010

Study contacts

Daniel Roth, MD
principal investigator · Vitreos retina center - NJ

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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