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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 email@example.com cant endothelial cell loss and low incident of opacities up to 10 years
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 firstname.lastname@example.org nates the risk of a second procedure.
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 email@example.com and did not lead to loss of BCVA.
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:firstname.lastname@example.org