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Completed

NCT Number: NCT00359008

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

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

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ha'emek Hospital

Afula, 18101, Israel

About this study

the study is prospective, multi-center, comparative

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Aug 1, 2006
Registry last updated
Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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