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

Overview

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

Full Title of Study: “PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

Detailed Description

the study is prospective, multi-center, comparative

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

Arms, Groups and Cohorts

  • 1
    • Intermediate AMD
  • 2
    • New untreated CNV subject

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Notal Vision Ltd
  • Provider of Information About this Clinical Study
    • Osnat Ehrman, NotalVision
  • Overall Official(s)
    • Ofer Sharon, MD, Study Director, Notal Vision

References

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.

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.

Bressler NM. Age-related macular degeneration is the leading cause of blindness… JAMA. 2004 Apr 21;291(15):1900-1.

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

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.

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