Outcomes and Complications of Implantable Collamer Lens and Toric Implantable Collamer Lens for the Correction of High Myopia with and without Astigmatism (One Year Prospective Study

Purpose: 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 Methods: In this prospective nonrandomized clinical trial, 95 eyes of 51 patients who underwent ICL (31 eyes) and toric ICL (64 eyes) implantations were participate in Eye Research Center, Department of Ophthalmology, Rasoul Akram Hospital, Tehran 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. Results: The mean preoperative manifest refractive spherical equivalents (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±0.63 D, -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. One eye (1.05%) developed asymptomatic (trace) anterior subcapsular opacities. Conclusion: ICL and toric ICL implantations were effective, predictable, and safe procedures for the treatment of high myopia and high myopic astigmatism.