We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
(never started)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01336907
First Posted: April 18, 2011
Last Update Posted: September 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Notal Vision Ltd
  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:


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


Enrollment: 0
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336907


Locations
France
Centre Hospitalier Intercommunal de Creteil
Paris, France
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:
Responsible Party: Notal Vision Ltd
ClinicalTrials.gov Identifier: NCT01336907     History of Changes
Other Study ID Numbers: HMP-DTR-01
First Submitted: April 13, 2011
First Posted: April 18, 2011
Last Update Posted: September 21, 2016
Last Verified: September 2016

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

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases