PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)

NCT ID: NCT00359008

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

336 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

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 PHP \& HPHP to detect newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD

Detailed Description

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the study is prospective, multi-center, comparative

The PHP is a class I FDA approved Device ( K050350 )

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

New untreated CNV subject

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with AMD related lesions:

Newly diagnosed (up to 6 months) non-treated CNV patients secondary to AMD in the study eye, or GA patients or Early and Intermediate AMD patients.

* Age ³ 50 for AMD patients
* VA with habitual correction in study eye 6/60 or better
* Mental and physical ability to perform a PHP/HPHP test
* Subject able and willing to sign consent form and participate in study
* Subject is not participating in another study when conducting the test

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 by biomicroscopy, fundus photography, or fluorescein angiography in the study eye
* Any non-macular related ocular surgery performed within 3 months prior to the study in the study eye
* CNV patient inability to tolerate intravenous fluorescein 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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Ha'emek Hospital

Afula, , Israel

Site Status

Countries

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Israel

References

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Alster Y, Bressler NM, Bressler SB, Brimacombe JA, Crompton RM, Duh YJ, Gabel VP, Heier JS, Ip MS, Loewenstein A, Packo KH, Stur M, Toaff T; Preferential Hyperacuity Perimetry Research Group. Preferential Hyperacuity Perimeter (PreView PHP) for detecting choroidal neovascularization study. Ophthalmology. 2005 Oct;112(10):1758-65. doi: 10.1016/j.ophtha.2005.06.008.

Reference Type BACKGROUND
PMID: 16154198 (View on PubMed)

Goldstein M, Loewenstein A, Barak A, Pollack A, Bukelman A, Katz H, Springer A, Schachat AP, Bressler NM, Bressler SB, Cooney MJ, Alster Y, Rafaeli O, Malach R; Preferential Hyperacuity Perimeter Research Group. Results of a multicenter clinical trial to evaluate the preferential hyperacuity perimeter for detection of age-related macular degeneration. Retina. 2005 Apr-May;25(3):296-303. doi: 10.1097/00006982-200504000-00008.

Reference Type BACKGROUND
PMID: 15805906 (View on PubMed)

Bressler NM. Age-related macular degeneration is the leading cause of blindness.. JAMA. 2004 Apr 21;291(15):1900-1. doi: 10.1001/jama.291.15.1900. No abstract available.

Reference Type BACKGROUND
PMID: 15108691 (View on PubMed)

Bressler NM. Early detection and treatment of neovascular age-related macular degeneration. J Am Board Fam Pract. 2002 Mar-Apr;15(2):142-52.

Reference Type BACKGROUND
PMID: 12002198 (View on PubMed)

Enoch JM, Williams RA, Essock EA, Barricks M. Hyperacuity perimetry. Assessment of macular function through ocular opacities. Arch Ophthalmol. 1984 Aug;102(8):1164-8. doi: 10.1001/archopht.1984.01040030942019.

Reference Type BACKGROUND
PMID: 6466179 (View on PubMed)

Related Links

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Other Identifiers

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PHP V3

Identifier Type: -

Identifier Source: org_study_id

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