- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Type d'étude
Contacts et emplacements
Lieux d'étude
-
-
-
Paris, France
- Centre Hospitalier Intercommunal de Créteil
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
---|
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)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Investigate the correlation between features of CNV lesions as measured with SD OCT and in the ForeseeHome.
Délai: 3-4 months
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Giuseppe Querques, Dr., Department of Ophthalmology, Centre Hospitalier Intercommunal de Creteil, University Paris XII, Paris, France
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HMP-DTR-01
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .