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Clinical outcomes of a new acrylic IOL with 22% water content
Session Title: New IOLs
Session Date/Time: Tuesday 08/10/2013 | 16:30-18:15
Paper Time: 16:36
Venue: Elicium 1 (First Floor)
First Author: : B.Dick GERMANY
Co Author(s): : J. Alio G. Lesieur S. Morselli B. Johansson
to evaluate the performance and the safety of a new acrylic micro incision lens. The Incise IOL has been designed in an enhanced acrylic material with 22% water content. The lens is designed with aberration free aspheric optics and 360° square edges less than 10 microns of radius.
5 European centers, University Eye Hospital Bochum, Germany
A prospective ethics committee approved clinical study is conducted including up to 100 patients. Biaxial (B-MICS) or micro coaxial (C-MICS) phacoemulsification procedures were equally performed using the Stellaris platform. The Incise(B+L) IOL was implanted with the Viscoject 1.5 inserter using two delivery techniques: 1.8mm in the bag, 1.4mm wound assist. UDVA, CDVA, manifest refraction, predictability of refraction were measured at 1-2 days (V1), 7-15 days (V2), 1-2 months (V3) and 4-6 months (V4) postoperatively.
On the first 57 eyes included, C-MICS with1.8 in the bag, B-MICS with1.4 wound assist were successfully performed in 29 cases and 28 cases, respectively. IOL SE power ranged from 16 to 27D. Mean age was 71.0 ±7.7 Years. At V3, mean UDVA was 0.09 ±0.14 logMAR(20/25), mean CDVA was -0.04 ±0.08 logMAR (20/20) with 95.7% of eyes with 20/25 or more. Mean Refraction was -0.26 ±0.54 with 74% within 0.50D and 96% of eyes within 1.00D of the intended refraction. No complications were reported.
Sub 2 mm cataract surgery with implantation of the Incise IOL is a safe and effective microincision procedure. The lens can be implanted through 1.4 mm wound assist or 1.8 mm in the bag, providing excellent visual and refractive outcomes. Longterm results will be evaluated to assess the posterior capsule opacification.