PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

NCT ID: NCT00358345

Last Updated: 2008-01-15

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

347 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-10-31

Study Completion Date

2007-09-30

Brief Summary

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The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV.

This study secondary is to enhance NotalVision normative database.

Detailed Description

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* The study is prospective, multi-center, comparative study.
* A clinical trail with FDA approval device (510K).

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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1

Intermediate AMD

No interventions assigned to this group

2

Newly diagnosed CNV

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD
* Age \>50 for AMD subjects
* Age \>18 for Myopic subjects
* VA 20/160 or better in the study eye
* Mental and physical ability to performed a PHP test

Exclusion Criteria

* Evidence of macular disease other than AMD or high myopia in the study eye.
* Previous surgical or laser treatment within the macular erea.
* Concurrent intraocular drug therapy (within 30 days).
* Present of any significant media opacity that preclude a clear veiw of the macula.
* Any non macular related ocular surgery performed within 3 months prior to the study.
* CNV subjects inability to tolerate intravenous fluorscien angiography.
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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NotalVision

Principal Investigators

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Ofer Sharon, MD

Role: STUDY_DIRECTOR

Notal Vision

Locations

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Tel Aviv Sourasky medical center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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PHP C9

Identifier Type: -

Identifier Source: org_study_id

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