RESUMO
IMPORTANCE: Intraocular collamer lenses (ICLs) are posterior chamber phakic lenses that provide a refractive surgery option for those with high myopia or astigmatism. The short-term and midterm results indicate good refraction stability, efficacy, and safety. Cataract has been suggested to be an important long-term complication of ICL implantation. OBJECTIVE: To report the rates of cataract development and refractive outcomes 10 years after ICL implantation. DESIGN, SETTING, AND PARTICIPANTS: The study included 133 eyes of 78 patients undergoing consecutive V4 model ICL implantations, which took place from January 1, 1998, through December 31, 2004, at Jules-Gonin Eye Hospital, Lausanne, Switzerland. Data analysis was performed from January 1, 2014, to May 31, 2014. The lenses implanted were as follows: 53 V4 model ICLs of -15.5 D or greater, 73 V4 model ICLs of less than -15.5 diopter (D), and 7 V4 model toric ICLs for myopia. MAIN OUTCOMES AND MEASURES: Rate of cataract surgery, lens opacity, ocular hypertension, refractive safety, predictability, and stability. RESULTS: A total of 133 eyes of 78 patients (34 men and 44 women, with a mean [SD] age of 38.8 [9.2] years at enrollment) met the inclusion criteria. The rate of lens opacity development was 40.9% (95% CI, 32.7%-48.8%) and 54.8% (95% CI, 44.7%-63.0%) at 5 and 10 years, respectively. Phacoemulsification was performed in 5 eyes (4.9%; 95% CI, 1.0%-8.7%) and 18 eyes (18.3%; 95% CI, 10.1%-25.8%) at 5 and 10 years after ICL implantation, respectively. The vault height (distance between the posterior ICL surface and anterior lens surface) measured a mean (SD) of 426 (344) µm immediately postoperatively, decreasing to 213 (169) µm at 10 years. A smaller vault height was associated with the development of lens opacity and phacoemulsification (P = .005 and .008, respectively). The intraocular pressure was 15 mm Hg postoperatively, and there was no significant increase in intraocular pressure observed until the 10-year follow-up (16 mm Hg, P = .02). At 10 years, 12 eyes (12.9%; 95% CI, 5.6%-19.6%) had developed ocular hypertension that required topical medication. At 10 years, the mean (SD) safety index was 1.25 (0.57), with a manifest spherical equivalent of -0.5 D at 1-year postoperatively vs -0.7 D at 10 years postoperatively in eyes aimed at emmetropia. CONCLUSIONS AND RELEVANCE: This retrospective single center study indicates that ICL implantation provides good long-term safety and stability of refraction in patients with high myopia compared with similar short-term studies. However, the rates of cataract formation and ocular hypertension at 10 years have important clinical implications, and as such this information should be part of the available patient information before ICL implantation.
RESUMO
PURPOSE: To assess the agreement and repeatability of horizontal white-to-white (WTW) and horizontal sulcus-to-sulcus (STS) diameter measurements and use these data in combination with available literature to correct for interdevice bias in preoperative implantable collamer lens (ICL) size selection. DESIGN: Interinstrument reliability and bias assessment study. METHODS: A total of 107 eyes from 56 patients assessed for ICL implantation at our institution were included in the study. This was a consecutive series of all patients with suitable available data. The agreement and bias between WTW (measured with the Pentacam and BioGraph devices) and STS (measured with the HiScan device) were estimated. RESULTS: The mean spherical equivalent was -8.93 ± 5.69 diopters. The BioGraph measures of WTW were wider than those taken with the Pentacam (bias = 0.26 mm, P < .01), and both horizontal WTW measures were wider than the horizontal STS measures (bias >0.91 mm, P < .01). The repeatability (Sr) of STS measured with the HiScan was 0.39 mm, which was significantly reduced (Sr = 0.15 mm) when the average of 2 measures was used. Agreement between the horizontal WTW measures and horizontal STS estimates when bias was accounted for was г = 0.54 with the Pentacam and г = 0.64 with the BioGraph. CONCLUSIONS: Large interdevice bias was observed for WTW and STS measures. STS measures demonstrated poor repeatability, but the average of repeated measures significantly improved repeatability. In order to conform to the US Food and Drug Administration's accepted guidelines for ICL sizing, clinicians should be aware of and account for the inconsistencies between devices.
