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OpenTrials
Completed

NCT Number: NCT01010997

Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

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Key information

About this study

The FORESEE HOME is intended for the early detection of central and paracentral irregularities (abnormalities) in the visual field, most commonly associated with AMD. However, the device has ability to detect the development of the lesion post treatment and therefore to asses in determination of the next treatment.

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 HOME 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 CNV under treatment or Intermediate AMD in at least one eye
  • Did not perform more then 10 anti- VEGF injections
  • Age >50 years
  • VA with habitual correction >6/45 in the study eye
  • Computer users

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

Treatment and study plan

Foresee Home

Device

using the Foresee home device

Primary outcomes

  1. To investigate the FORESEE HOME ability to diagnose AMD in different stages

    Time frame: 1 year

Secondary outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Notal Vision Ltd.

Industry

Registry information

Acronym: Foresee Home

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Nov 10, 2009
Registry last updated
Jul 31, 2012

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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