Multicountry clinical outcomes of a new nondiffractive presbyopia-correcting IOL
| Autor: | Ali A. Mearza, Jessie Lemp-Hull, Chandra Bala, Merce Guarro, Francisco Poyales, Srichand Jasti, Ramon Ruiz Mesa, Devesh K. Varma |
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| Přispěvatelé: | [Bala C] PersonalEyes, Sydney, Australia. [Poyales F] Miranza IOA Madrid Innova Ocular, Madrid, Spain. [Guarro M] OMIQ-Hospital General de Catalunya, Barcelona, Spain. Hospital General de Granollers, Granollers, Spain. [Mesa RR] Oftalvist CIO Jerez, Puerta del Sur Hospital, Cádiz, Spain. [Mearza A] Imperial College Healthcare NHS Trust & Ophthalmic Consultants of London, London, United Kingdom. [Varma DK] Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Ontario, Canada. Prism Eye Institute, Oakville, Ontario, Canada. Trillium Health Partners, Mississauga, Ontario, Canada. [Jasti S, Lemp-Hull J] Alcon Laboratories, Inc., Fort Worth, Texas, Hospital General de Granollers |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
genetic structures medicine.medical_treatment intervenciones quirúrgicas::procedimientos quirúrgicos oftalmológicos::procedimientos quirúrgicos refractivos::extracción de catarata::facoemulsificación [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Intraocular lens Prosthesis Design Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics::Epidemiologic Studies::Cohort Studies::Prospective Studies [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] intervenciones quirúrgicas::procedimientos quirúrgicos oftalmológicos::procedimientos quirúrgicos refractivos::implantación de lentes intraoculares [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] CLs upper limits Lens Implantation Intraocular Ophthalmology medicine Humans Pròtesis Prospective Studies Surgical Procedures Operative::Ophthalmologic Surgical Procedures::Refractive Surgical Procedures::Lens Implantation Intraocular [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] Lenses Intraocular Monocular Phacoemulsification Facoemulsificació business.industry Surgical Procedures Operative::Ophthalmologic Surgical Procedures::Refractive Surgical Procedures::Cataract Extraction::Phacoemulsification [ANALYTICAL DIAGNOSTIC AND THERAPEUTIC TECHNIQUES AND EQUIPMENT] Presbyopia Lents intraoculars medicine.disease eye diseases Sensory Systems Bilateral Cataracts técnicas de investigación::métodos epidemiológicos::características de los estudios epidemiológicos::estudios epidemiológicos::estudios de cohortes::estudios prospectivos [TÉCNICAS Y EQUIPOS ANALÍTICOS DIAGNÓSTICOS Y TERAPÉUTICOS] Visual Disturbance Surgery business Multi country Photopic vision |
| Zdroj: | Scientia |
| ISSN: | 1873-4502 |
| Popis: | Implantació de lents intraoculars; Facoemulsificació; Estudis prospectius Implantación de lentes intraoculares; Facoemulsificación; Estudios prospectivos Lens Implantation Intraocular; Phacoemulsification; Prospective Studies Purpose: To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF. Setting: 19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom. Design: Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study. Methods: Participants aged ≥22 years with bilateral cataracts were randomized to DFT015 or SN60WF in a 5:4 ratio and masked until final postoperative follow-up at month 6. The primary effectiveness objective was superiority of DFT015 over SN60WF in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) at month 3. Secondary effectiveness objectives included noninferiority of DFT015 to SN60WF in mean monocular photopic corrected distance visual acuity (CDVA) and superiority in the mean monocular photopic distance-corrected near visual acuity (DCNVA) at month 3. Visual disturbances were assessed at month 6. Results: 282 patients were randomized to DFT015 (n = 159) or SN60WF (n = 123). All effectiveness objectives were achieved at month 3 in first eyes. For monocular photopic results in first eyes, DFT015 demonstrated superior mean DCIVA (least squares means of -0.139 logMAR in favor of DFT015, P < .001), noninferior mean CDVA (97.5% upper confidence limit [UCL] of the difference was |
| Databáze: | OpenAIRE |
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