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Comparison Between Home Macular Perimeter and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)

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Notal Vision

Status

Withdrawn

Conditions

Choroidal Neovascularization
Age Related Macular Degeneration

Study type

Observational

Funder types

Industry

Identifiers

NCT01336907
HMP-DTR-01

Details and patient eligibility

About

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

The Optical Coherence Tomography (OCT) may be used as well to identify choroidal neovascularization (CNV). Comparison between the two methods will allow better understanding of both devices.

The FORESEE HOME can be used as an assessment tool for the progression and success of the treatment given to AMD lesions. Therefore, evaluating the size and the location of the treated lesions may serve as an additional tool.

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • For naïve CNV lesion - diagnosed in less than 60 days. OR For re-activated CNV lesion - treated more than 4 month from the diagnosis.

    • Intent to treat the study eye (SE)
    • Corrected VA better than 6/45 (20/150) in SE
    • Subject is capable and willing to sign a consent form and participate in the study
    • Age > 55 years
    • Subject declared that he or she knows how to operate a computer mouse

Exclusion criteria

  • Evidence of macular disease other than AMD or glaucoma in SE
  • Presence of any significant media opacity that precludes a clear view of the macular area as identified in the SE by biomicroscopy
  • Any ocular surgery performed within 3 months prior to study entry in the SE * Participation in another study

Trial design

0 participants in 2 patient groups

naive CNV subjects
Description:
Newly diagnosed CNV, before any treatment (naïve)
previously diagnosed CNV subjects
Description:
Previously diagnosed CNV if last treatment is older than 4 months (reactivated)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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