Outcomes and Complications of Implantable Collamer Lens and Toric Implantable Collamer Lens for the Correction of High Myopia with and without Astigmatism

To evaluate the efficacy, safety, predictability and stability of Implantable Collamer Lens (ICL) and toric ICL for the treatment of high myopia and high myopic astigmatism, one year prospective study. In this prospective nonrandomized clinical trial, 95 eyes of 51 patients that had ICL (31 eyes) and toric ICL (64 eyes) were participate in Eye Research Center, Department of Ophthalmology, Rasoul Akram Hospital, Iran University of Medical Sciences and Negah Eye Hospital, Tehran, Iran. Uncorrected visual accuity (UCVA), best spectacle corrected visual acuity (BSCVA), manifest refraction, adverse events and complications were evaluated at 5th day and 2, 6 and 12 months postoperation. The preoperative mean manifest refractive spherical equivalent (MRSE) were 11.75±4.63 D (diopter) (-5.0 to -22.0) in ICL group and -11.67±3.99 D (-3.0 to -21.0) in toric ICL group. Mean residual refractive spherical equivalent were -0.68±1.07 D at 5th day, -0.86±1.07 D at 2 months, 0.65±0.72 D at 6 months, -0.71±0.78 D at one year in ICL group and -0.69±1.03 D, -0.59±0.84 D, -0.71±0.76 D and 0.89±0.68 D in toric ICL group, respectively. Preoperative cylinder in toric ICL group was -3.25±1.29 D (-2.0 to -6.0) and after operation was - 0.81±0.63D, -0.75±0.67 D, -0.93±0.70 D, -0.94±0.61 D, respectively. At 2 months after operation, the UCVA was 20/40 or better in 74.3% in ICL group and 74.6 % in toric ICL group (efficacy=1.092 and 1.154, respectively). 71.0% and 68.2% were within ±0.5 D and 77.5% and 85.7% were within ±1.0 D of emmetropia, respectively. 58.1% and 63.6% gained one or more lines (safety=1.18 and 1.24) two months after operation. At 2 months after operation, 81%, of eyes in toric ICL group had <1.0 D and 95.3% <1.5 D cylinder. No operative and postoperative complications or adverse events were observed. Asymptomatic (trace) anterior sub capsular opacities were seen in one eye (1.05%). ICL and toric ICL were effective, predictable, and safe procedures for the treatment of high myopia and high myopic astigmatism.