Evaluation of clinical outcomes following implantation of a sub-2-mm hydrophilic acrylic MICS intraocular lens

• Published in: International ophthalmology Vol. 39; no. 5; pp. 1043 - 1054
• Main Authors: Dick, H. Burkhard, Schultz, Tim, Lesieur, Gilles, Morselli, Simonetta, Toso, Antonio, Alio, Jorge L., Buckhurst, Phillip J., Johansson, Björn
• Format: Journal Article
• Language: English
• Published: Dordrecht Springer Netherlands 01.05.2019; Springer Nature B.V
• Subjects: Acuity; Cataracts; Clinical outcomes; Evaluation; Eye; Eye (anatomy); Eye lens; Implantation; Intraocular lens; Intraocular pressure; Medicine; Medicine & Public Health; Microincision cataract surgery; Ophthalmology; Original Paper; Refraction; Stability analysis; Surgery; Visual acuity; Intraocular lens; Implantation; Microincision cataract surgery
• ISSN: 0165-5701; 1573-2630; 1573-2630
• DOI: 10.1007/s10792-018-0905-3

Purpose To evaluate clinical outcomes following sub-2-mm microincision cataract surgery (MICS) and intraocular lens (IOL) implantation. Setting Five EU clinical sites. Design Prospective, multicenter, open-label, single-arm, non-randomized. Methods Preoperative assessment involved visual acuity (VA), intraocular pressure and biometry measurements. 1.4-mm wound-assisted or 1.8-mm MICS was performed. Follow-up visits were made 1 day, 1–2 weeks, 1–2 and 4–6 months after surgery. The incision size, corrected distance VA (CDVA), uncorrected distance VA, manifest refraction spherical equivalent (MRSE), refraction predictability/stability and IOL decentration were assessed. At 12-, 18-, and 24-month, long-term centration, posterior capsular opacification (PCO) and Nd:YAG capsulotomy rates were investigated. Results A total of 103 eyes were implanted with the study IOL (INCISE, Bausch & Lomb), 96 of which were included in visual outcome analysis. A mean 6-month CDVA of − 0.02 logMAR (20/20 + 1) was observed and 75 eyes (79.8%) and 93 eyes (98.3%) achieved a visual acuity of at least 20/20 or 20/40. Mean MRSE was − 0.20 ± 0.60 D. Mean absolute predictive error was 0.44 ± 0.36 D, with 90.4% within 1.00 D of target. Mean total decentration was 0.35 ± 0.36 mm at 6 months and 0.32 ± 0.14 mm at 24 months ( p  > 0.05). 24-month evaluation of posterior capsular opacification score was 0.03 for the central area. A Nd:YAG rate of 3.4% was observed at 24 months. Conclusions The new MICS IOL provided excellent visual outcomes and was safe and effective for the sub-2-mm procedure. The MICS IOL demonstrated long-term centration, stability and a low rate of PCO development.