Capsular bag performance of a novel hydrophobic acrylic single-piece intraocular lens: Two-year results of a randomised controlled trial

Abstract

Purpose: To determine the visual outcome, intraocular lens (IOL) stability and posterior capsule opacification (PCO) rate of a hydrophobic acrylic intraocular lens. Setting: Vienna Institute for Research in Ocular Surgery, Hanusch Hospital, Vienna, Austria Design: This double-masked randomised study included patients who underwent standard cataract surgery. Method: Patients received either the hydrophobic acrylic IOL (iPure, PhysIOL) or the hydrophobic acrylic control IOL (Tecnis ZCB00, Johnson&Johnson). Subjective refraction, uncorrected and corrected distance visual acuity (UDVA, CDVA), IOL tilt and decentration (Purkinje meter) and PCO intensity using retroillumination images with automated image analysis (automated quantification of after-cataract, AQUA), were evaluated for both groups 2 years after surgery. Results: A total number of 31 patients completed the 2-year follow-up, 16 in the study group and 15 in the control group. The CDVA was 0.0 logMAR (standard deviation – SD: 0.1) for the study IOL and 0.1 logMAR (SD: 0.2) for the control IOL, p = 0.001. The AQUA PCO score for the study group was 2.1 and 1.4 for the control group, p = 0.44. Mean IOL tilt was 2.9° (SD: 1.8) in the study group and 5.0° (SD: 4.5) in the control group, whilst the mean decentration was 0.37 mm (SD: 0.18) and 0.45 mm (SD: 0.3), p = 0.610. Conclusion: The studied parameters revealed a good performance for both IOLs. Both IOLs had good CDVA, a small amount of tilt and decentration and none of the patients required laser capsulotomies during the follow-up time of 2 years after surgery. Presented at the 37th ESCRS Congress Paris, France, September 2019