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

Notal Vision

Status: Completed

Conditions: Age Related Macular Degeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT00359008

PHP V3

Details and patient eligibility

About

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 description

the study is prospective, multi-center, comparative

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

Enrollment: 336 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

336 participants in 2 patient groups

1

Description:

Intermediate AMD

2

Description:

New untreated CNV subject