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

NCT ID: NCT01336907

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL

Brief 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.

Conditions

Age Related Macular Degeneration; Choroidal Neovascularization

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

naive CNV subjects

Newly diagnosed CNV, before any treatment (naïve)

No interventions assigned to this group

previously diagnosed CNV subjects

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

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Notal Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giuseppe Querques, Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France

Locations

Centre Hospitalier Intercommunal de Creteil

Paris, , France

Countries

France

Related Links

http://www.notalvision.com

sponsor's site

Other Identifiers

HMP-DTR-01

Identifier Type: -

Identifier Source: org_study_id