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Evaluation of clinical outcomes following implantation of a sub-2-mm hydrophilic acrylic MICS intraocular lens
University Eye Hospital Bochum, Bochum, Germany.
University Eye Hospital Bochum, Bochum, Germany.
Centre Ophtalmologique Iridis, Albi, France.
Ospedale di Bassano del Grappa Bassano del Grappa, Bassano del Grappa, Italy.
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2019 (English)In: International ophtalmology, ISSN 0165-5701, E-ISSN 1573-2630, Vol. 39, no 5, p. 1043-1054Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
Springer Netherlands, 2019. Vol. 39, no 5, p. 1043-1054
Keywords [en]
Implantation, Intraocular lens, Microincision cataract surgery
National Category
Ophthalmology
Identifiers
URN: urn:nbn:se:liu:diva-153462DOI: 10.1007/s10792-018-0905-3ISI: 000467649400009PubMedID: 29654574Scopus ID: 2-s2.0-85045259988OAI: oai:DiVA.org:liu-153462DiVA, id: diva2:1272631
Available from: 2018-12-19 Created: 2018-12-19 Last updated: 2019-06-22Bibliographically approved

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Johansson, Björn

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Division of Neuro and Inflammation ScienceFaculty of Medicine and Health SciencesDepartment of Ophthalmology in Linköping
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