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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00359008

Enrollment

336

Registered

2006-08-01

Start date

2006-07-31

Completion date

2007-09-30

Last updated

2008-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age Related Macular Degeneration

Keywords

AMD, CNV, PHP

Brief summary

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

Detailed description

the study is prospective, multi-center, comparative The PHP is a class I FDA approved Device ( K050350 )

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Countries

Israel

Outcome results