Comparison of the Hoya Surgical Optics (HSO) iSert 251 Posterior Chamber Aspheric Aphakic Intraocular Lens to Historical / Literature Controls.
Paraules clau
Resum
Descripció
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.
Dates
| Darrera verificació: | 02/28/2015 |
| Primer enviat: | 02/03/2011 |
| Inscripció estimada enviada: | 02/03/2011 |
| Publicat per primera vegada: | 02/08/2011 |
| Última actualització enviada: | 03/17/2015 |
| Publicació de l'última actualització: | 03/19/2015 |
| Data dels primers resultats enviats: | 02/10/2015 |
| Data dels primers resultats de control de qualitat enviats: | 03/17/2015 |
| Data dels primers resultats publicats: | 03/19/2015 |
| Data d'inici de l'estudi real: | 01/31/2011 |
| Data estimada de finalització primària: | 04/30/2012 |
| Data estimada de finalització de l’estudi: | 04/30/2012 |
Condició o malaltia
Intervenció / tractament
Device: Investigational intraocular lens
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Investigational intraocular lens iSert 251 intraocular lens | Device: Investigational intraocular lens aphakic intraocular lens |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 50 Years Per a 50 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: - Have been diagnosed with cataract for which phacoemulsification extraction and posterior chamber IOL implantation is indicated - Have clear intraocular media - Have potential Best Corrected Visual Acuity of 20/40 or better - Have preoperative Best Spectacle-Corrected visual acuity of 20/40 or worse Exclusion Criteria: - Have ocular pathology or abnormalities that do or are expected to reduce best corrected visual acuity in the operative eye during the study period - Are monocular - Have current ocular infection - Are taking systemic steroids or other anti-metabolites - Have previous retinal detachment in the operative eye or expect to require retinal laser treatment during the course of the study Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information. |
Resultat
Mesures de resultats primaris
1. Visual Acuity [4 to 6 months]
Mesures de resultats secundaris
1. Complications and Adverse Events [4 to 6 months]
