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Age-Related Macular Degeneration (AMD) - Usability Study

NCT ID: NCT00963339

Last Updated: 2010-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Age Related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dry AMD

subjects diagnosed as intermediate AMD in at least one eye

Foresee Home

Intervention Type DEVICE

Home Monitoring

Interventions

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Foresee Home

Home Monitoring

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Notal Vision Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Notal Vision

Principal Investigators

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Daniel Roth, MD

Role: PRINCIPAL_INVESTIGATOR

Vitreos retina center - NJ

Other Identifiers

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US02

Identifier Type: -

Identifier Source: org_study_id