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

Age Related Macular Degeneration Clinical Trial

Official title:

Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01336907
• Other study ID #: HMP-DTR-01
• Status: Withdrawn
• Phase: N/A
• First received: April 13, 2011
• Last updated: September 20, 2016

Study information

• Verified date: September 2016
• Source: Notal Vision Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Creteil	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Notal Vision Ltd

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3-4 months	No

External Links

•   sponsor's site