PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)
NCT ID: NCT00359008
Last Updated: 2008-01-15
Study Results
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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COMPLETED
336 participants
OBSERVATIONAL
2006-07-31
2007-09-30
Brief Summary
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Detailed Description
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The PHP is a class I FDA approved Device ( K050350 )
Conditions
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Study Design
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COHORT
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
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
* 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
50 Years
ALL
No
Sponsors
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Notal Vision Ltd.
INDUSTRY
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
Countries
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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.
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.
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.
Bressler NM. Early detection and treatment of neovascular age-related macular degeneration. J Am Board Fam Pract. 2002 Mar-Apr;15(2):142-52.
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.
Related Links
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Company Site
Other Identifiers
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PHP V3
Identifier Type: -
Identifier Source: org_study_id
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