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.
Keywords: Implantation; Intraocular lens; Microincision cataract surgery.