2018年,國(guó)內(nèi)分別上市了VICMO和VTICMO兩款產(chǎn)品(具體如下表所示),其光學(xué)直徑為4.9~5.8mm,相較于VICMO和VTICMO,VICM5和VTICM5有更大的光學(xué)區(qū),其光學(xué)直徑為5.0~6.1mm,晶體屈光度-0.5D到-14.0D。
近年來(lái)臨床應(yīng)用反饋,VICM5對(duì)于大瞳孔患者的臨床效果及在改善術(shù)后夜視力,潛在減少術(shù)后眩光及光暈等方面優(yōu)于VICMO。
自2015年12月16日VICM5和VTICM5獲得CE證書后在歐洲各國(guó)、日本、韓國(guó)及香港地區(qū)陸續(xù)上市并廣泛應(yīng)用于臨床,***近幾年(2015.12-2021.7)全球銷量VICM5為178,629枚;VTICM5為136,141枚。其******性安全性得到充分驗(yàn)證,在不同人種的臨床效果未見(jiàn)顯著性差異。
EVO+ ICL產(chǎn)品介紹
EVO+ ICL產(chǎn)品型號(hào)
ICL光學(xué)區(qū)
EVO+產(chǎn)品革新
相比較于現(xiàn)有產(chǎn)品,V5有助于減少患者在術(shù)后可能發(fā)生的眩光光暈等主觀視覺(jué)異常,可進(jìn)一步提高患者的夜視力體驗(yàn),能滿足大瞳孔的屈光不正的患者及對(duì)視覺(jué)質(zhì)量有極高要求的屈光不正患者,提高患者的滿意度。
EVO+(VICM5 & VTICM5) 全球應(yīng)用概況
EVO+(VICM5 & VTICM5) 2011年3月25日獲得CE證書后在歐洲各國(guó)、日本、韓國(guó)及香港地區(qū)陸續(xù)上市并廣泛應(yīng)用于臨床
EVO+產(chǎn)品特點(diǎn)
1、不切除任何角膜組織(1,2)
No corneal tissue removal – Great for thin corneas(1,2)
2、視覺(jué)質(zhì)量高1,出色的夜間視力(3),不會(huì)引起干眼(4)
Vision Quality – Improved Visual Acuity1, Excellent Night Vision3, No induction of dry eye syndrome4
3、Collamer材料制成,超高生物相容性(5,6)
Made of Collamer - Highly biocompatible, inhibiting inflammatory responses to achieve a postoperative quiet (5,6)
4、超過(guò)1,000,000例的全球植入量
Proven track record – over 1,000,000 lenses implanted globally
5、提供紫外線保護(hù)
UV Protection
6、臨床報(bào)道中患者滿意度高(7)
Reported High Patient Satisfaction in a clinical study-(7)
可潛更大的光學(xué)區(qū)
在減少患者在術(shù)后可能發(fā)生的眩光光暈等主觀視覺(jué)異常
更佳的夜視力體驗(yàn)
可滿足大瞳孔的屈光不正的患者及對(duì)視覺(jué)質(zhì)量有極高要求的屈光不正患者
1.Parkhurst G, Psolka M, Kezirian G. Phakic intraocular lens implantation in United States military warfighters: A retrospective analysis of early clinical outcomes of the Visian ICL. J Refract Surg. 2011;27(7):473-481.
2.Gimbel H, et al. Management of myopic astigmatism with phakic intraocular lens implantation. Journal of Cataract & Refractive Surgery, Volume 28, Issue 5 , 883 – 886.
3.Parkhurst G. A prospective comparison of phakic Collamer lenses and wavefront-optimized laser-assisted in situ keratomileusis for correction of myopia. Clinical Ophthalmology. 2016.
4.Naves J, Carracedo G, Cacho-Babillo I. Diadenosine nucleotide measurements as dry-eye score in patients after LASIK and ICL surgery. Presented at American Society of Cataract and Refractive Surgery (ASCRS) 2012.
5.Schild G, Amon M, Abela-Formanek C, et al. Uveal and capsular biocompatibility of a single-piece, sharp-edged hydrophilic acrylic intraocular lens with collagen (Collamer): 1-year results. J Cataract Refract Surg. 2004 Jun;30(6):1254-8.
6.Brown D, Ziémba S. Collamer IOL FDA Study Group. Collamer intraocular lens: clinical results from the US FDA core study. J Cataract Refract Surg. 2001 Jun;27(6):833-40.
7.MICL PMA data: P030016.
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