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

This study has suspended participant recruitment.
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT01336907
First received: April 13, 2011
Last updated: October 28, 2013
Last verified: October 2013

April 13, 2011
October 28, 2013
June 2012
December 2013   (final data collection date for primary outcome measure)
Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome. [ Time Frame: 3-4 months ] [ Designated as safety issue: No ]
  1. Height of Pigment Epithelial Detachment
  2. Sub Retinal Fluid Thickness
  3. Maximum Diameter of Largest Retinal Cyst
  4. Maximum Retinal Thickness
  5. Central Retinal Thickness
Same as current
Complete list of historical versions of study NCT01336907 on ClinicalTrials.gov Archive Site
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Comparison Between Home Macular Perimeter and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)
Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

CNV subjects

  • Age Related Macular Degeneration
  • Choroidal Neovascularization
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  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
March 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01336907
HMP-DTR-01
No
Notal Vision Ltd
Notal Vision Ltd
Not Provided
Principal Investigator: Giuseppe Querques, Dr. Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France
Notal Vision Ltd
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP