Usability of the PreView PHP for Home Use in Intermediate AMD Patients

NCT ID: NCT00776451

Last Updated: 2009-06-03

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

66 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-03-31

Brief Summary

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To demonstrate the ability of intermediate AMD subjects to follow the instructions for use and properly operate on their own the Preview PHP in home use environment, after going through training session.

Detailed Description

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The study purpose is to demonstrate that the target population can use the system after going through a supervised training session. The PreView PHP will be operated in the same manner in the simulated setting as it will be in future home use.

Conditions

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Age Related Macular Degeneration

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Subjects diagnosed with Dry AMD

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Capable and willing to sign a consent form and participate in the study Subjects diagnosed as intermediate AMD in at least one eye
* Age ≥65 years
* VA with habitual correction better than 20/60 in the study eye
* Ability to speak, read and understand instructions in English or Hebrew
* Qualified to use the device by health care professional

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, CFP.
* Any non-macular related ocular surgery or macular surgery performed within 3 months prior to study entry in the target eye
* Participation in another study with the exclusion of AREDS study
* Patients diagnosed with geographic atrophy (GA)
Minimum Eligible Age

65 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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Neil Bressler, Prof.

Role: PRINCIPAL_INVESTIGATOR

JHMC

Locations

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Belinson Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Related Links

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Other Identifiers

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PHP-US-01

Identifier Type: -

Identifier Source: org_study_id

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