- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01336907
Comparison Between Home Macular Perimeter and Optical Coherence Tomography (OCT) Visual Field Defects in Patients With Choroidal Neovascularization (CNV)
Comparison Between Home Macular Perimeter and OCT Visual Field Defects in Patients With CNV
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.
Studieoversigt
Status
Undersøgelsestype
Kontakter og lokationer
Studiesteder
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Paris, Frankrig
- Centre Hospitalier Intercommunal de Creteil
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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naive CNV subjects
Newly diagnosed CNV, before any treatment (naïve)
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previously diagnosed CNV subjects
Previously diagnosed CNV if last treatment is older than 4 months (reactivated)
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.
Tidsramme: 3-4 months
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the measures are Height of Pigment Epithelial Detachment , Sub Retinal Fluid Thickness , Maximum Diameter of Largest Retinal Cyst , Maximum Retinal Thickness , Central Retinal Thickness
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3-4 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Giuseppe Querques, Dr., Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HMP-DTR-01
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