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Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

NCT ID: NCT01010997

Last Updated: 2012-07-31

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

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-01-31

Brief Summary

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The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

Detailed Description

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The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Conditions

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Age Related Macular Degeneration

Keywords

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AMD, CNV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dry AMD

Intermediate AMD subjects

Foresee Home

Intervention Type DEVICE

using the Foresee home device

Wet - treated AMD

AMD subjects under treatments

Foresee Home

Intervention Type DEVICE

using the Foresee home device

Interventions

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Foresee Home

using the Foresee home device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Capable and willing to sign a consent form and participate in the study
* Subjects diagnosed as CNV under treatment or Intermediate AMD in at least one eye
* Did not perform more then 10 anti- VEGF injections
* Age \>50 years
* VA with habitual correction \>6/45 in the study eye
* Computer users

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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Responsibility Role SPONSOR

Principal Investigators

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Eliezer Kraus, MD

Role: PRINCIPAL_INVESTIGATOR

Naharia Hospital

Locations

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Naharia Hospital

Nahariya, , Israel

Site Status

Countries

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Israel

Other Identifiers

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75909

Identifier Type: OTHER

Identifier Source: secondary_id

FORESEE HOME- 02

Identifier Type: -

Identifier Source: org_study_id