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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 is not yet open for participant recruitment.
Verified February 2012 by Notal Vision Ltd
Sponsor:
Information provided by (Responsible Party):
Notal Vision Ltd
ClinicalTrials.gov Identifier:
NCT01336907
First received: April 13, 2011
Last updated: February 2, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Age Related Macular Degeneration
Choroidal Neovascularization

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Notal Vision Ltd:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/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)

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

CNV subjects

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336907

Contacts
Contact: Osnat Ehrman +972 3 6293763 osnat@notalvision.com

Locations
France
Centre Hospitalier Intercommunal de Creteil Not yet recruiting
Paris, France
Contact: Giuseppe Querques, Dr.            
Sponsors and Collaborators
Notal Vision Ltd
Investigators
Principal Investigator: Giuseppe Querques, Dr. Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France
  More Information

Additional Information:
sponsor's site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT01336907     History of Changes
Other Study ID Numbers: HMP-DTR-01
Study First Received: April 13, 2011
Last Updated: February 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Notal Vision Ltd:
CNV
AMD
Wet-treated CNV

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Scotoma
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
 Pathologic Processes
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 19, 2013