- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Studietyp
Kontakter och platser
Studieorter
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Paris, Frankrike
- Centre Hospitalier Intercommunal de Créteil
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Giuseppe Querques, Dr., Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France
Publikationer och användbara länkar
Användbara länkar
Studieavstämningsdatum
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HMP-DTR-01
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