PURPOSE: To assess Visian Implantable Collamer Lens (ICL) (STAAR Surgical, Monrovia, CA) implantation in the ciliary sulcus to correct pseudophakic ametropia in patients who are not candidates for a keratorefractive procedure. METHODS: The authors performed a prospective non-comparative case series study of 18 patients (age: 48 to 61 years) with refractive surprise after phacoemulsification. Patients underwent implantation of a piggyback collagen copolymer lens: V4C design in 16 myopic eyes and V4B design in 2 hyperopic eyes. The position and vault of the ICLs were documented at all control visits clinically and with Pentacam (Oculus Optikgeräte, Wetzlar, Germany). Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), intraocular pressure (IOP), and endothelial cell count were recorded at baseline and 1 week and 1, 6, 12, and 18 months postoperatively. RESULTS: The MRSE improved from -3.08 ± 2.37 diopters (D) preoperatively to -0.44 ± -0.23 D postoperatively, corrected with a mean ICL power of -3.20 ± 2.90 D. The mean UDVA improved from 1.03 ± 0.12 logMAR preoperatively to 0.05 ± 0.06 logMAR postoperatively (P = .00), whereas CDVA improved from 0.47 ± 0.03 logMAR preoperatively to -0.006 ± 0.02 logMAR (P = .001) postoperatively. None of the cases developed interlenticular opacification throughout the 18-month follow-up. The mean ICL vault measured by Scheimpflug tomography was 451.27 ± 178.5 µm. Acute IOP elevation with anterior uveitis developed in 2 eyes and was controlled by topical steroids and a beta-blocker. CONCLUSIONS: Sulcus implantation of the secondary ICL to correct pseudophakic refractive error was safe, predictable, and well tolerated in all studied eyes. [J Refract Surg. 2017;33(8):532-537.]. Copyright 2017, SLACK Incorporated.
RCT Entities:
PURPOSE: To assess Visian Implantable Collamer Lens (ICL) (STAAR Surgical, Monrovia, CA) implantation in the ciliary sulcus to correct pseudophakic ametropia in patients who are not candidates for a keratorefractive procedure. METHODS: The authors performed a prospective non-comparative case series study of 18 patients (age: 48 to 61 years) with refractive surprise after phacoemulsification. Patients underwent implantation of a piggyback collagen copolymer lens: V4C design in 16 myopic eyes and V4B design in 2 hyperopic eyes. The position and vault of the ICLs were documented at all control visits clinically and with Pentacam (Oculus Optikgeräte, Wetzlar, Germany). Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), intraocular pressure (IOP), and endothelial cell count were recorded at baseline and 1 week and 1, 6, 12, and 18 months postoperatively. RESULTS: The MRSE improved from -3.08 ± 2.37 diopters (D) preoperatively to -0.44 ± -0.23 D postoperatively, corrected with a mean ICL power of -3.20 ± 2.90 D. The mean UDVA improved from 1.03 ± 0.12 logMAR preoperatively to 0.05 ± 0.06 logMAR postoperatively (P = .00), whereas CDVA improved from 0.47 ± 0.03 logMAR preoperatively to -0.006 ± 0.02 logMAR (P = .001) postoperatively. None of the cases developed interlenticular opacification throughout the 18-month follow-up. The mean ICL vault measured by Scheimpflug tomography was 451.27 ± 178.5 µm. Acute IOP elevation with anterior uveitis developed in 2 eyes and was controlled by topical steroids and a beta-blocker. CONCLUSIONS: Sulcus implantation of the secondary ICL to correct pseudophakic refractive error was safe, predictable, and well tolerated in all studied eyes. [J Refract Surg. 2017;33(8):532-537.]. Copyright 2017, SLACK Incorporated.