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Prospective multicenter clinical trial to evaluate the visual outcomes, glistenings and posterior capsule opacification after implantation of a new hydrophobic glistening-free IOL: 6 months follow-up

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First Author: D.Schiano Lomoriello ITALY

Co Author(s):    D. Schiano Lomoriello   C. Komaiha   I. Abicca   A. Manfredi   A. Pocobelli        

Abstract Details

Purpose:

The purpose of this prospective, non-randomized, controlled, multi-surgeon, multi-centre study is to determine the visual performance of MicroPure 1.2.3 IOL (PhysIOL SA, Liège, Belgium) in cataract patients. The MicroPure 1.2.3 is a preloaded monofocal glistening-free hydrophobic acrylic IOL. Primary end point of this study is to evaluate Corrected Distance Visual Acuity (CDVA) at 6 months of follow-up and compare it to literature data on a different monofocal IOL. Secondary outcomes are Uncorrected Distance Visual Acuity (UDVA), contrast sensitivity under photopic and mesopic conditions, assessment of glistenings and PCO.

Setting:

'-Azienda Ospedaliera San Giovanni Addolorata. Presidio Britannico. Oftalmologia – Banca degli Occhi. Rome, Italy -Istituto di Ricovero e Cura a carattere scientifico (IRCCS) – Fondazione G.B. Bietti - Rome, Italy

Methods:

This study included 94 eyes implanted with Micropure 1.2.3. All subjects under 45 years of age, with irregular astigmatism or regular astigmatism; 0.75 D, ocular comorbidities and acute or chronic systemic disease were excluded from the study. The surgery was carried out using standard phacoemulsification technique with a 2.4 mm incision. Surgeons target a 5.5 mm diameter capsulorhexis to allow the optic to be fully overlapped by the anterior capsular rim. The use of a unique viscoelastic device was necessary to avoid bias. All patients underwent follow-up visits at 1 day, 1 week, 1 month and 6 months post-surgery.

Results:

The interim results of 94 eyes at 1 month and 37 eyes at 6 months show mean postoperative MRSE slightly myopic (-0.26D) at 1 month, reducing at 6 months (0.02D). Refractive predictability almost on target (1W: +0.05D, 1M: +0.06D). Values are in LogMAR. Monocular Contrast Sensitivity outcomes well within the normal band of this age group. At 6 months follow up (140 to 220 days after surgery), mean UDVA was 20/24. The mean CDVA was 20/20. Data analysis showed no glistening event during the follow-up. No Nd:YAG laser capsulotomy has been performed during the follow-up for the occurrence of PCO.

Conclusions:

Occurrence of IOL glistenings can impact on the pseudophakic patient’s vision quality . Micropure 1.2.3 show good restoration of visual performance in terms of incidence of PCO and glistening after implantation. This result is probably due to the glistening-free material which matches the “no space, no cells” concept. The bio-adhesiveness of this material and the design of the lens integrates the 2-step technology which features a 360° square edge barrier and a posterior haptic angulation leads to a continuous barrier against PCO. The outcomes of the a longer follow up will be presented.

Financial Disclosure:

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