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OpenTrials
Completed

NCT Number: NCT00692887

Correlation Between Visual Field Defects on Foresee Preferential Hyperacuity Perimeter(PHP) and on Optical Coherence Tomography (OCT) in Patients With Choroidal Neovascularization (CNV)

Study come to investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).

To investigate the Foresee PHP ability to asses treatment progression post treatment.

Completed

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sorasky Medical center

Tel Aviv, Israel

About this study

The Foresee PHP is used in the recent years to detect Age-related Macular Degeneration (AMD) lesions. The device is capable of differentiation as to stages of AMD and early detection of changes including choroidal neovascularization (CNV) The Foresee PHP™ demonstrates a high level of sensitivity and specificity as to the different stages of AMD including newly diagnosed or early detection of CNV.

The OCT May be use as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The Foresee PHP can use as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluation the size and the location of the treated lesions may serve as an additional tool.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Capable and willing to sign a consent form and participate in the study
  • Subjects diagnosed as new CNV or treated CNV
  • Age >50 years
  • VA with habitual correction <20/160 in the study eye
  • Ability to understand instructions

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 in the study eye by biomicroscopy,
  • Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye
  • Patients diagnosed with geographic atrophy (GA)
  • Participation in another study with the exclusion of AREDS study

Treatment and study plan

PHP - Preferential Hyperacuity Perimeter (Foresee)

Device

computerized test

Other names: PHP 2.0.5, OCT - optical coherence tomography

Primary outcomes

  1. To investigate the correlation between visual fields (VF) defects map generated by preferential hyperacuity perimeter (PHP) and features of the choroidal neovascular lesions (CNV) demonstrated by Optical Coherence Tomography(OCT).

    Time frame: 6 month

Secondary outcomes

  1. To investigate the Foresee PHP ability to asses treatment progression post treatment.

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Official study title

Correlation Between Visual Field Defects on Foresee PHP and OCT in Patients With CNV Before and After Treatment

Acronym: PHP

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Jun 6, 2008
Registry last updated
Jan 28, 2009

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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