Purpose: To evaluate the postoperative rotational stability of two prototype intraocular lens (IOL) designs (subsequently termed version 1 and version 2). Patients and Methods: A prospective, multicenter, randomized, paired-eye, 6-month study evaluated the version 1 and version 2 IOLs. Results were compared with a control IOL (TECNIS ® toric 1-piece monofocal IOL) evaluated in a separate, similarly designed study. Participants aged ≥22 years and scheduled to undergo bilateral cataract extraction were randomly assigned 1:1 to receive the version 1 or version 2 IOL in the first operative eye; the alternate test IOL was then implanted in the second operative eye. Results: Mean absolute IOL rotation at postoperative week 1 was the primary effectiveness end point. Additional end points included the percentage of eyes with postoperative IOL rotation >5°/>10°, direction of lens rotation, surgeon-reported ease of IOL handling during implantation, and safety. At postoperative week 1, mean (±standard deviation) absolute IOL rotation was significantly lower for both version 1 and version 2 versus control (0.88° [±0.94] and 0.71° [±0.69] vs 2.24° [±3.21], respectively; both P < 0.001). For both study lenses, absolute rotation was <5° for all eyes at postoperative week 1, and no cases of rotation >10° were observed at any postoperative time point. From postoperative week 1 onward, version 2 had a statistically significant clockwise bias in the direction of rotation (P = 0.03); similar findings were observed for version 1. Surgeons reported acceptable ease of IOL handling during implantation for both version 1 and version 2. No device-related adverse events were reported. Conclusion: Both the version 1 and version 2 IOLs, each with frosted, squared haptics, demonstrated improved postoperative rotational stability compared with a control lens without frosted haptics. Because version 2 had the same overall geometry as the current TECNIS toric IOL, this design was selected for commercialization. Trial Registration: German Clinical Trials Register, DRKS00015287.
PURPOSE:To investigate changes in tear film surface quality after commencing soft contact lens wear. METHODS: Tear film surface quality (TSQ) was assessed during the interblink period using dynamic videokeratoscopy at 25 Hz. A quantitative value of TSQ is derived for each raw Placido ring image. Eleven young subjects with normal tear characteristics participated in the study. Dynamic videokeratoscopy was taken three times per day; in the morning, at lunchtime, and in the afternoon. This was done on two baseline days (bare eye) and on the first and seventh days of lens wear for a conventional hydrogel lens and following a week of no lens wear, for a further week of silicone hydrogel lens wear. Additionally clinical tests to assess TSQ were conducted and subjects were also asked to rate the subjective dryness of their eyes. RESULTS: All lens wear measurements showed a significant worsening of TSQ compared to bare eye measurements (repeated measures ANOVA, P<0.01). A significant diurnal change was found on the first day of silicone hydrogel contact lens wear, where TSQ improved during the day (P=0.045). However, no diurnal changes were found in TSQ for the other lens wearing days or for the bare eye condition (P>0.05). The subjective rating of dryness correlated with TSQ values (Pearson's r=0.62, P<0.05) for the bare eye condition, but not during contact lens wear. TSQ derived from the right and left bare eyes of the same individuals showed a significant correlation (Pearson's r=0.61, P<0.05). CONCLUSIONS: The measurement of TSQ using dynamic videokeratoscopy differentiates between bare eye and lens wearing conditions. It also shows a small systematic improvement in tear surface quality during the first day of silicone hydrogel lens wear and a significant association with subjective dryness for the bare eye condition. (J Optom 2008;1:14-21 ©2008 Spanish Council of Optometrists) KEY WORDS: high speed videokeratoscopy; tear film; dry eye; contact lens. RESUMEN OBJETIVO:Investigar los cambios en la calidad de la superficie de la película lagrimal tras empezar a utilizar lentes de contacto blandas. MÉTODOS: Se evaluó la calidad de la superficie de la película lagrimal (CSPL) durante el periodo comprendido entre dos parpadeos consecutivos utilizando videoqueratoscopia (topografía corneal estándar) dinámica a 25 Hz. Para cada imagen registrada de los anillos de Plácido se derivó un valor cuantitativo de la CSPL. En el estudio participaron once sujetos jóvenes cuya lágrima presentaba características normales. Se realizaron medidas de videoqueratoscopia dinámica tres veces al día: por la mañana, a la hora de comer y por la tarde. Estas medidas se llevaron a cabo primero, en dos días distintos, para recabar datos de referencia (ojo desnudo, sin lente de contacto); posteriormente, el primer y el séptimo día de uso de una lente de contacto convencional de hidrogel y finalmente, y tras una semana sin utilizar lentes, se realizaron medidas el primer y el séptimo día de uso de una lente de hidrogel de silicona. De maner...
Purpose To evaluate the reproducibility of magnitude of postoperative IOL rotation following implantation of a toric intraocular lens (IOL) with modified haptics, in comparison with a Proof-of-Concept (POC) study of prototype IOLs featuring the same haptic design. Patients and Methods A post-market, prospective, multicenter, single-arm, open-label clinical study was conducted. TECNIS Toric II IOL (Johnson & Johnson Vision, Irvine, CA, USA, Models ZCU150 to 600) were implanted in 125 subjects and evaluated at 1-day and 1-week postoperatively. An objective photographic method was used to determine postoperative IOL rotation. Uncorrected distance visual acuity (UCDVA), postoperative astigmatism, and surgeon satisfaction were also assessed. Rotation data were compared to the POC study in which two prototype non-toric monofocal IOLs, one with the same haptic design as Model ZCU, were studied. Results Mean absolute rotation was 0.82° ± 1.0° and 0.84° ± 0.92°at 1-day and 1-week visits, respectively. The percentage of eyes with ≤5° of absolute rotation was 98.9% and 99.5% at the 1-day and 1-week visits, respectively. The magnitude of rotation was similar to the POC study prototype IOLs. At 1-week, mean monocular UCDVA was 0.026 ± 0.135 (~20/21) logMAR and mean residual manifest refractive cylinder was 0.30 D ± 0.35 D. The mean signed axis difference (postoperative minus operative) of the TECNIS Toric II IOL was 0.23° ± 1.27° at 1-day and −0.07° ± 1.25° at 1-week, indicating a clockwise drift. At 1-week, surgeons were very satisfied or satisfied with overall clinical outcomes and rotational stability in 98% of implanted eyes. Conclusion The TECNIS Toric II IOL, with frosted, squared haptics, demonstrated low magnitude of postoperative IOL rotation, excellent uncorrected distance vision, and minimal residual astigmatism. The POC study design was supported, demonstrating that prototype non-toric monofocal IOLs can predict clinical performance of toric IOLs with the same haptic design.
A new silicone hydrogel daily disposable toric combines two unique technologies to deliver excellent comfort and clear, stable vision, with a wide parameter range. Benjamin Straker, Giovanna Olivares, Anna Sulley and David Ruston report.
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