Evaluation of clinical outcomes following implantation of a sub-2-mm hydrophilic acrylic MICS intraocular lens
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To evaluate clinical outcomes following sub-2-mm microincision cataract surgery (MICS) and intraocular lens (IOL) implantation.
Five EU clinical sites.
Prospective, multicenter, open-label, single-arm, non-randomized.
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.
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.
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.
KeywordsIntraocular lens Implantation Microincision cataract surgery
The authors confirm that they have made a significant contribution to this study and have read and approved the final version of the manuscript.
This clinical research was initiated and financially supported by Bausch & Lomb. None of the authors have a financial or proprietary interest in any material or method mentioned in this paper. Dr Johansson, Prof Dick, Dr Morselli, Dr Toso received travel support for scientific meetings.
Compliance with ethical standards
Conflict of interest
There are no conflicts of interest to disclose.
All procedures performed in this study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments.
Informed consent was obtained from all individual participants included in the study.
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