Age-Related Macular Degeneration (AMD) - Usability Study (AMD)

September 22, 2010 updated by: Notal Vision Ltd.
The purpose of this study is to evaluate the usability of the Foresee Home device with intermediate AMD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

54

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Intermediate AMD

Description

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

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dry AMD
subjects diagnosed as intermediate AMD in at least one eye
Device: Foresee Home
Home Monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Successful unpacking and installation
Time Frame: 3 months
3 months
Successful self tutorial performance
Time Frame: 3 months
3 months
Ability of the subjects to operate the device as define by a successful test completion
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the success rate of the interactive tutorial as defined by a reliable test result.
Time Frame: 3 month
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Notal Vision Ltd.

Investigators

  • Principal Investigator: Daniel Roth, MD, Vitreos retina center - NJ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

August 20, 2009

First Submitted That Met QC Criteria

August 20, 2009

First Posted (Estimate)

August 21, 2009

Study Record Updates

Last Update Posted (Estimate)

September 23, 2010

Last Update Submitted That Met QC Criteria

September 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • US02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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