PreView PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization

Notal Vision

Status: Completed

Conditions: Age Related Macular Degeneration

Study type: Observational

Funder types: Industry

Identifiers

NCT00358345

PHP C9

Details and patient eligibility

About

The primary objective of this study is to assess the ability of the PreView PHP(study device)to detect newly diagnosed non-treated Choroidal Neovascularization (CNV)lesion associate with advanced Age-related Macular Degeneration (AMD) or Myopia and differentiate them from Intermediate AMD or Geographic Atrophy (GA)or patients with high Myopia with no CNV.

This study secondary is to enhance NotalVision normative database.

Full description

• The study is prospective, multi-center, comparative study.
• A clinical trail with FDA approval device (510K).

Enrollment: 347 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed (up yo 2 months) CNV OR Intermediate AMD
• Age >50 for AMD subjects
• Age >18 for Myopic subjects
• VA 20/160 or better in the study eye
• Mental and physical ability to performed a PHP test

Exclusion criteria

• Evidence of macular disease other than AMD or high myopia in the study eye.
• Previous surgical or laser treatment within the macular erea.
• Concurrent intraocular drug therapy (within 30 days).
• Present of any significant media opacity that preclude a clear veiw of the macula.
• Any non macular related ocular surgery performed within 3 months prior to the study.
• CNV subjects inability to tolerate intravenous fluorscien angiography.

Trial design

347 participants in 2 patient groups

1

Description:

Intermediate AMD

2

Description:

Newly diagnosed CNV