RESUMEN
Purpose: To evaluate rotational stability, tilt and decentration of a new monofocal IOL with a 7.0 mm optic and frame haptics.Methods: Prospective post-market clinical follow-up study at the Kepler University Hospital Linz, Austria. An Aspira-aXA (HumanOptics, Germany) was implanted in 74 eyes of 42 cataract patients. The lens was manufactured with toric markings. IOL rotational stability was evaluated by comparing its position at the end of surgery (EoS) versus 1 day, 1 week, 1 month and 4 months postoperatively. IOL tilt and decentration were measured using a Scheimpflug camera at 1 week, 1 month and 4 months.Results: Median absolute IOL rotation was 1.42 degrees (n = 52; mean = 2.18 ± 2.23°) within 1 day after surgery and was significantly higher compared to all later intervals (median <1.0 degree; P = .001). At the 4 months follow-up, IOL rotation was within 5.0 degrees in 85% of the eyes (n = 40) and within 10.0 degrees in 98% (n = 46) of the eyes. The only eye with an IOL rotation of ≥ 10.ty0 degrees (EoS vs. 1 day) had an AL of 26.45 mm. At the last follow-up, the IOL vertical and horizontal tilt referenced to the pupillary axis was in average less than 1.5 degrees in both eyes (n = 54; maximum 5.85°). Decentration in both meridians was on average less than 0.10 mm in both eyes (maximum 0.30 mm).Conclusion: The one-piece Aspira-aXA IOL showed good and stable positioning within the capsular bag over a 4 months period.
Asunto(s)
Migracion de Implante de Lente Artificial/fisiopatología , Implantación de Lentes Intraoculares , Lentes Intraoculares , Facoemulsificación , Seudofaquia/fisiopatología , Rotación , Anciano , Anciano de 80 o más Años , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Óptica y Fotónica , Fotograbar/instrumentación , Vigilancia de Productos Comercializados , Estudios Prospectivos , Diseño de Prótesis , Refracción Ocular/fisiologíaRESUMEN
PURPOSE: To compare the lens tilt after apex-centered capsulotomy with standard pupil-centered capsulotomy. SETTING: Clinical practice. DESIGN: Prospective, randomized, investigator-masked trial. METHODS: This prospective, randomized, investigator masked study included 40 patients with age-related cataract scheduled for femtosecond laser-assisted cataract surgery (FLACS) in both eyes. The main outcome was the tilt of the intraocular lens (IOL), measured with the IOLMaster 700. RESULTS: The study enrolled 80 eyes of 40 patients. The mean distance from the center of the apex-centered capsulotomy to the pupil-centered capsulotomy was 175.8 ± 97.2 µm. The amount of IOL tilt was not significantly reduced with the new technique (P > .05). Tilt orientation was more stable in eyes treated with apex-centered capsulotomy. CONCLUSIONS: Centration of the capsulotomy on the lens apex in FLACS does not influence the amount of IOL tilt but the orientation stability. The clinical importance of this finding has to be further elucidated.