Visual and Patient-Reported Outcomes of a Diffractive Trifocal Intraocular Lens Compared with Those of a Monofocal Intraocular Lens
| Autor: | Vance Thompson, Jeffrey Horn, Bret Fisher, Andrew Maxwell, Jerry G. Hu, Robert J. Cionni, Satish Modi, Kerry D Solomon, Elizabeth Yeu, Robert Lehmann, Michael Caplan |
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| Rok vydání: | 2020 |
| Předmět: |
Male
medicine.medical_specialty Visual acuity genetic structures Pseudophakia medicine.medical_treatment Visual Acuity Intraocular lens Refraction Ocular Cataract Confirmatory trial 03 medical and health sciences 0302 clinical medicine Lens Implantation Intraocular Ophthalmology Surveys and Questionnaires medicine Humans Patient Reported Outcome Measures Prospective Studies 030304 developmental biology Aged Lenses Intraocular 0303 health sciences Vision Binocular Phacoemulsification business.industry Cataract surgery Multifocal intraocular lens Middle Aged Multifocal Intraocular Lenses eye diseases Eyeglasses 030221 ophthalmology & optometry Female sense organs medicine.symptom business Monocular vision Photopic vision |
| Zdroj: | Ophthalmology. 128(2) |
| ISSN: | 1549-4713 |
| Popis: | To evaluate the effectiveness and safety of a trifocal intraocular lens (IOL), the TFNT00 (Alcon, Fort Worth, TX), versus a monofocal IOL, the SN60AT (Alcon).Food and Drug Administration-approved, prospective, multicenter, nonrandomized, parallel-group, assessor-masked, confirmatory trial.Patients enrolled were 22 years of age or older with a diagnosis of bilateral cataract with planned removal by phacoemulsification with a clear corneal incision.Consented participants selected their preferred IOL, which was implanted sequentially into each eye of patients meeting eligibility criteria.The coprimary effectiveness outcomes were mean photopic monocular best-corrected distance visual acuity (BCDVA; 4 m) and distance-corrected near visual acuity (DCNVA; 40 cm) at 6 months after surgery. Secondary effectiveness outcomes included mean monocular distance-corrected intermediate visual acuity (DCIVA; 66 cm) and proportion of participants responding "never" to question 1 of the Intraocular Lens Satisfaction questionnaire (regarding frequency of spectacle use in the past 7 days). Safety outcomes included frequency of "severe" and "most bothersome" visual disturbances.Two hundred forty-three patients underwent cataract surgery with bilateral implantation of the TFNT00 (n = 129) or SN60AT (n = 114) and were followed up for 6 months. Noninferiority of TFNT00 to SN60AT in mean photopic monocular BCDVA (95% upper confidence limit of the difference was0.1 logarithm of the minimum angle of resolution [logMAR] margin), and superiority in mean photopic monocular DCNVA (difference of 0.42 logMAR; P0.001) and DCIVA (difference of 0.26 logMAR; P0.001) were demonstrated. The proportion of patients never requiring glasses overall was superior for TFNT00 versus SN60AT (80.5% and 8.2%, respectively). Starbursts, halos, and glare were the most frequently rated severe symptoms with TFNT00; however, less than 5% of patients were very bothered at month 6.The TFNT00 exhibited superior monocular DCNVA and DCIVA to a spherical monofocal IOL, with comparable monocular BCDVA. Binocular visual acuity was 20/25 or better for distance to near (+0.5 D to -2.5 D), resulting in high levels of spectacle independence. Less than 5% of patients were very bothered by the photic visual disturbances associated with the TFNT00 at 6 months after surgery. |
| Databáze: | OpenAIRE |
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