Foresee Home for Monitoring Age Related Macular Degeneration (AMD)

NCT01010997 — Completed, 10 participants, Notal Vision Ltd.

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RegistryNCT01010997, acronym Foresee Home
StatusCompleted
Study typeObservational
Enrollment10 (Actual)
SponsorNotal Vision Ltd. (Industry)
ConditionsAge Related Macular Degeneration
InterventionsForesee Home (Device)
Datesstart 2009-12-01, primary completion 2012-01-01, completion 2012-01-01, first posted 2009-11-10, last updated 2012-07-31
Locations1 site in Israel

Related Papers Related Patents Related Grants Related Experts
All trials for Age Related Macular Degeneration All trials of Foresee Home

-Summary

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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+Detailed description

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.

+Arms and interventions

ArmTypeInterventionsDescription
Dry AMDDevice: Foresee HomeIntermediate AMD subjects
Wet - treated AMDDevice: Foresee HomeAMD subjects under treatments
  • Foresee Home (Device): using the Foresee home device

+Outcome measures

Primary outcomes

  • To investigate the FORESEE HOME ability to diagnose AMD in different stages [1 year]

Secondary outcomes

  • 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). [1 year]

+Eligibility

Sex: All, ages: 50 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Naharia HospitalNahariyaIsrael

+Investigators