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WithdrawnNCT01336907Updated Sep 21, 2016

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

An observational study in Age Related Macular Degeneration and Choroidal Neovascularization, sponsored by Notal Vision Ltd.. Withdrawn at 1 site in France. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2016-09-21.

Sponsored by Notal Vision Ltd. · Observational

Why this study was withdrawn
never started
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
55 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Age Related Macular Degeneration
  • Choroidal Neovascularization

Keywords

  • CNV
  • AMD
  • Wet-treated CNV
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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

Browse Macular Degeneration studies →

Lead sponsor

Notal Vision Ltd. is the lead sponsor of 25 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

CNV subjects

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)

Groups and cohorts

  • naive CNV subjects

    Newly diagnosed CNV, before any treatment (naïve)

  • previously diagnosed CNV subjects

    Previously diagnosed CNV if last treatment is older than 4 months (reactivated)

06

What researchers measure

Primary outcomes

  1. Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.

    the measures are Height of Pigment Epithelial Detachment , Sub Retinal Fluid Thickness , Maximum Diameter of Largest Retinal Cyst , Maximum Retinal Thickness , Central Retinal Thickness

    Time frame: 3-4 months

07

Study locations

1 site
  • Centre Hospitalier Intercommunal de Creteil
    Paris, France
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References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01336907
Lead sponsor
Notal Vision Ltd.
Responsible party
Sponsor
First posted
Apr 18, 2011
Last update
Sep 21, 2016

Study contacts

Giuseppe Querques, Dr.
principal investigator · Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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