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31 lr high_l_feb_2012_staar_public[1]
31 lr high_l_feb_2012_staar_public[1]
31 lr high_l_feb_2012_staar_public[1]
31 lr high_l_feb_2012_staar_public[1]
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31 lr high_l_feb_2012_staar_public[1]

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  • 1. Page 1 Literature Review Highlights February 2012 Inside This Long-term Results Of Posterior Chamber Phakic Intraocular Lens Issue Implantation For Correction Of High Ametropia By Le Loir,M and Cochener,B. Journal français d’ophthalmologie (Original article in French) Ahead of printLong-term ICL Safe-ty: 5-year outcomes This article assesses the efficacy, stability and safety of posterior chamber phakic intraocular lensPage 1 implantation with the STAAR Visian ICL for correction of high ametropia, with an average follow- up of 4.7 years (3.5-10 years).Bioptics (ICH+LVC): Sample descriptionHyperopic astigma-tism correction  90 eyes of 53 patients with high ametropia (45 myopia, 10 hyperopiaPage 2 and 35 with mixed astigmatism)  Retrospective study using the V4 ICL model (87 eyes)Toric ICL in eyes with  Mean pre-operative myopia of –12.06D, hyperopia +8.03D (rangePDM: myopic astigma- from –6 to –23D, and from +4.5 to +10D), combined astigmatismtism correction between 1.75 and 3.25DPage 3  Mean ICL power of –14.9D (myopia), and +7.5D (hyperopia)AXL after ICL  All patients in the study were from 18 to 45 years oldPage 4 Results  Efficacy: UCVA at 1 month post-operatively was at least 20/40 in 80% of the eyes, and at least 20/20 in 57% of the eyes  Predictability: Post-operative mean spherical equivalent was within 1D from target at 1 month postoperatively, while 64% of the eyes were within 0.5 from expected SE  Safety: At 3 years BCVA improved up to 2 lines or remained unchanged in 92% of the eyes  Patient satisfaction: At 6-months post-operatively 96% of patients responded “yes” to the question “Would you have chosen this surgery again?”  Safety parameters:  IOP did not seem to be influenced by the presence of ICL throughout the follow- Pre-op up. Only 3 cases showed transient IOP spike due to retention of viscoelastic  Post-operatively, mean central vault was 0.52±0.20 mm and did not show a sig- 60 months nificant decrease over time  5 cases of anterior capsular opacification and only 3 cases of clinically significant cataracts (over 43 years of the age and with high myopia, and with ICL V3 model Central corneal endothelial cell density (in cells/mm2) in one case) before and up to 60 months after the ICL implantation  ECC showed a decrease of 3.78% during the first year due to surgical trauma. After the first year, ECC decreased at a rate of 0.69% per year throughout the entire follow-up  This study did not show any significant changes in pupil diameter from the first through the 48th post-operative month  Although narrowing of the iridocorneal angle post-operatively was significant, it was not associated to an increase in intraocular pressure or trabecular pigmenta- Post-op ACD (endo-to-ICL) remains stable throughout the follow-up tion, and remained stable throughout the entire follow-up Author’s conclusion ICL implantation is a leading treatment for correcting moderate to high ametropia that guaran- tees excellent refractive results and stable safety over time Take-home message For further  This study demonstrates the efficacy, stability and safety of the Visian ICL for the correction ofinformation, please high ametropia contact:  This study further supports the long-term safety after implantation of the Visian ICL; no signifi-clinical@staarag.ch cant endothelial cell loss and low incident of opacities up to 10 years
  • 2. Page 2 Literature Review Highlights February 2012 Phakic Collamer Lens (ICL) Implantation Followed By Excimer La- ser Treatment (Bioptics) To Correct Hyperopia With Astigmatism By J.F.Alfonso et al. J Emmetropia 2011; 2: 181-187 The present study assesses the efficacy and safety results on bioptics with spherical ICL im- plantation (ICHV3 model) for correction of low to high hyperopia followed by LVC (LASIK or PRK) to treat residual astigmatism. Sample description  62 eyes of 35 patients  Mean age was 27.6.4±4.3 years (20 to 40 years)  50 out of these 62 eyes underwent LASIK and 12 eyes had PRK procedure  Mean interval between ICHV3 implantation and LVC was 4.9±3.9 months (3 to 19 moths)  Mean follow-up after LVC treatment was 9.7±7.4 months (3 to 27 months) Results  Mean SE improved from +5.73± 1.79D (+1.5 to +11D) to -0.01±0.08D (-0.50 to +0.25D)  Mean cylinder improved from –2.07±1.03D (0 to –4D) to -0.19±0.36D (0 to –1.5D)  Post-operatively 99% of the eyes were within 0.5D from expected SE and 94% of the eyes were within 0.5D from expected cylinder (see figure)  Post-operatively 94% of the eyes had UCVA ≥20/40 and 69% of the eyes had UCVA≥20/25  Efficacy and safety indexes were 0.99 and 1.04 respectively  None of the eyes lost >2 lines of BCVA  75% of the eyes maintained or gained lines of BCVA after bioptics procedure  No intra-operative or post-operative complications occurred Author’s conclusion Bioptics procedure combining ICH implantation and LVC showed to be a safe procedure to treat hyperopia associated with astigmatism when hyperopic toric ICLs are not available. The author observed better results of predictability with the bioptics approach when com- pared with similar previous studies using hyperopic PRK or LASIK (see references 30. and 31. in the full text PDF) Take-home message  Bioptics procedure combining hyperopic Visian ICL and LVC seems to be an effective and For further safe procedure for correction of hyperopic astigmatism.information, please  Visian hyperopic Toric ICL (from +0.5 to +10D including any combination with cylinder from 0.5 contact: to 6D), available since September of 2010, may avoid subsequent laser ablation with elimi-clinical@staarag.ch nates the risk of a second procedure.
  • 3. Page 3 Literature Review Highlights February 2012 Toric Collagen Copolymer Phakic Intraocular Lens To Correct Myopic Astigmatism In Eyes With Pellucid Marginal Degeneration By G.D. Camoriano et al. J Cataract Refract Surg 2012; 38:256-261 Retrospective study which evaluates the visual outcomes of Visian Toric ICL (V4 model) implanta- tion for correction of high myopic astigmatism in eyes with pellucid marginal degeneration (PMD). Sample description  10 eyes of 5 patients with mild PMD  Mean age was 37.4±2.6 years  Pre-operative MRSE was –6.71±0.09D and MRCyl was 4.4±1.1D (2.5 to 6.75)  Follow-up was 6 months Results  MRSE improved to -0.58±0.1D  Post-operatively 70% of the eyes were within 0.5D from expected SE and 90% of the eyes were within 1.0D SE  Post-operatively 100% of the eyes had UCVA ≥20/40 and 57% of the eyes had UCVA≥20/20  Safety index was 1.1  None of the eyes lost ≥2 lines of BCVA  Post-operatively BCVA improved or remained unchanged almost in most of the eyes (almost 50% gained ≥1 line)  1 case of exchange due to glare and halo and hyperopic refractive surprise. After removal, TICL was repositioned due to residual astigmatism. The most likely reason was a combina- tion of a post-operative change in the corneal topography and slight shift in the position of the TICL. After repositioning the patient remained satisfied with her vision.  No intra-operative or post-operative complications occurred Author’s conclusion Implantation of Toric ICL is a safe and effective surgical procedure for the correction of myopic astigmatism in eyes with PMD. Take-home message  This article further supports the excellent performance of the Visian Toric ICL in challenging cases of eyes with degenerative corneal conditions such as keratoconus or PMD. For further  Excellent predictability of the Visian Toric ICL for correction of high myopic astigmatism (upinformation, please to 6.75D) contact:  Low incidence of adverse events;1 case of exchange+repositioning which was manageableclinical@staarag.ch and did not lead to loss of BCVA.
  • 4. Page 4 Literature Review Highlights February 2012 Axial Length Measurement In Eyes Implanted With Phakic Posterior Chamber Intraocular Lenses By Elies,D, Alfonso,J.F et al. J Emmetropia 2011;2:9-11 The aim of this prospective study is to analyze if the presence of myopic Visian ICL/Toric ICL (V4 model) would interfere with axial length (AXL) measurements using optical biometry (partial coher- ence interferometry technology). Sample description  32 eyes of 19 patients  Pre-operative MRSE was -13.73±4.48D (-5.5 to -21D)  Mean ICL power (Sph) was -13.53±4.37D (-5.50 to -21D)  Mean ICL power (Cyl) was -4.17±1.04D (0 to +5D) Results  Mean AXL difference between before and after ICL implantation was no statistically signifi- cant = -0.03±0.12mm (-0.17 to 0.10mm)  High correlation between AXL measurements before and after ICL implantation (see figure) Author’s conclusion ICL implantation does not affect axial length measurement using optical biometry. Furthermore, optical biometry is a valid and reliable technique for AXL measurements on ICL implanted eyes. Take-home message  Axial length does not seem to be affected by the presence of myopic ICL and Toric ICL. Thus, in those eyes having an ICL and requiring cataract surgery at a later date, axial length and IOL power calculation do not have to be modified  Other previous studies, Hoffer1and Khokhar2, showed that the presence of ICL did not affect AXL measurement when using ultrasound biometry 1. Hoffer,KJ.Ultrasound axial length measurement in biphakic eyes. J Cataract Refract Surg 2003;29:961-965 2. Khokhar SK, Agarwal T, Dave V. Comparison of preoperative and postoperative axial length measurement with immersion A-scan in ICL cases. J Cataract Refract Surg 2009;35:2168-2169 For furtherinformation, please contact:clinical@staarag.ch

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