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

NCT01336907 | Withdrawn

• 1 other identifier: HMP-DTR-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

CNV; AMD; Wet-treated CNV

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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 Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

CNV subjects

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Notal Vision Ltd.: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Creteil

Paris, France

Location

Related Links

• sponsor's site

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Giuseppe Querques, Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2011
• First Posted: April 18, 2011
• Last Updated: September 21, 2016

Record last verified: 2016-09

Locations

FR (1)