17～21岁屈光不正患者接受有晶体眼人工晶状体V4c植入术临床观察
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摘要
目的探讨有晶体眼人工晶状体(ICL) V4c植入术治疗年轻(17～21岁)屈光不正患者的有效性、安全性。方法行ICL V4c植入术治疗的屈光不正患者40例(80眼),分为观察组(17～21岁) 17例(34眼)、对照组23例(> 21岁)(46眼),观察并记录术前及术后24个月的裸眼视力(Snellen视力表,Log MAR UDVA)、矫正视力(Snellen视力表,CDVA)、屈光状态(等效球镜度数)、有效性(术后裸眼视力,有效性指数)、安全性(术后矫正视力,安全性指数)、可预测性(术后等效球镜的分布)、稳定性(等效球镜和高阶像差的变化趋势)、高阶像差、单眼调节幅度、人工晶状体拱高、角膜内皮细胞计数、不良反应等临床资料,并进行比较。结果有效性:两组术后裸眼视力均较术前改善,术后6、12个月,两组Log MAR UDVA比较,P <0. 05。术后24个月,观察组UDVA≥0. 6者34眼(100%),≥0. 8者32眼(94. 2%),≥1. 0者30眼(88. 2%),有效性指数1. 07;对照组分别为46 (100%)、41(89. 1%)、37眼(80%),有效性指数1. 05。两组各时间点Log MAR CDVA比较,P均<0. 05。安全性指数分别为1. 14和1. 09。两组的可预测性类似,观察组的稳定性稍差,但两组等效球镜比较,P均> 0. 05。两组术后24个月的总高阶像差、球差、慧差均较术前有所增加(P均<0. 05)。在瞳孔直径为6 mm情况下,观察组术后24个月的慧差较对照组降低(P <0. 05),两组其余高阶像差比较,P均> 0. 05。观察组术后各时点AMP均高于术前(P均<0. 05),对照组术后1、24个月AMP高于术前(P均<0. 05);两组各时点AMP比较,P均<0. 05。两组人工晶状体拱高、角膜内皮细胞数比较,P均﹤0. 05。随访期间未发现明显并发症。结论应用ICL V4c植入术矫正17～21岁屈光不正患者具有良好有效性、安全性。
Objective To investigate the effectivenessand safety of implantable collamer lens( ICL) V4 c implantation for younger patients( 17-21 yearsold) with ametropia. Methods Forty patients( 80 eyes) undergoing ICL V4 cimplantation were divided into two groups based on age: 34 eyes in the observation group( 17≤age≤21 years old) and 46 eyes in the control group( age > 21 yearsold). The uncorrected visual acuity( UCVA),corrected distance visual acuity( CDVA),refractive statuses( spherical equivalents,SE),effectiveness( UDVA,effectiveness index),safety( CDVA,safety index),predictability( postoperative SE distribution),stability( SE and HOA variation tendency),higher order aberration( HOA),amplitude of accommodation,ICL vaults,corneal endothelial cells,and adverse events were evaluatedbefore and 24 months after surgery. Results Effectiveness: the postoperative UDVA of both groups were obviously improved compared with the preoperative UDVA. UDVA of the observation group was more ideal than that of control group at 0. 5 and 1 year after operation( P < 0. 05). In the observation group,34 eyes had UDVA≥0. 6( 100%),32 eyes≥0. 8( 94. 1%),30 eyes≥1. 0( 88. 2%),and the effectiveness index was 1. 07 at 2 years after surgery. In the control group,46 eyes had UDVA≥0. 6( 100%),41 eyes≥0. 8( 89. 1%),37 eyes≥1. 0( 80. 4%),and the effectiveness index was 1. 05 at 2 years after surgery. Safety: the average postoperative CDVA of the observation group was better than that of the control group( P < 0. 05),and the safety index was 1. 14 in observation group and 1. 09 in the control group. The predictability was similar in both groups,but the stability of the observation group was a bit poor,without statistical difference( P > 0. 05). The higher-order aberrations,total difference,spherical and coma aberration in both groups at 2 years after operation were higher than those beforeoperation,but 6 mm pupil diameter inthe observation group was lower than that of the control group( P < 0. 05). The AMP improved at 0. 5,1,and 2 years after operation in the observation group while the AMP improved at 1 and 2 years postoperatively in the control group( P < 0. 05). The AMP was more quickly and greater in the observation group at three time pointsas compared with that of the control group( P < 0. 05). As for vaults,endothelial cell density and adverse events,both of the two groups showed similar results. Conclusion Application of ICL V4 c implantation for refractive errors has good effetiveness and safety in ametropia patients of 17-21 years old.
Objective To investigate the effectivenessand safety of implantable collamer lens( ICL) V4 c implantation for younger patients( 17-21 yearsold) with ametropia. Methods Forty patients( 80 eyes) undergoing ICL V4 cimplantation were divided into two groups based on age: 34 eyes in the observation group( 17≤age≤21 years old) and 46 eyes in the control group( age > 21 yearsold). The uncorrected visual acuity( UCVA),corrected distance visual acuity( CDVA),refractive statuses( spherical equivalents,SE),effectiveness( UDVA,effectiveness index),safety( CDVA,safety index),predictability( postoperative SE distribution),stability( SE and HOA variation tendency),higher order aberration( HOA),amplitude of accommodation,ICL vaults,corneal endothelial cells,and adverse events were evaluatedbefore and 24 months after surgery. Results Effectiveness: the postoperative UDVA of both groups were obviously improved compared with the preoperative UDVA. UDVA of the observation group was more ideal than that of control group at 0. 5 and 1 year after operation( P < 0. 05). In the observation group,34 eyes had UDVA≥0. 6( 100%),32 eyes≥0. 8( 94. 1%),30 eyes≥1. 0( 88. 2%),and the effectiveness index was 1. 07 at 2 years after surgery. In the control group,46 eyes had UDVA≥0. 6( 100%),41 eyes≥0. 8( 89. 1%),37 eyes≥1. 0( 80. 4%),and the effectiveness index was 1. 05 at 2 years after surgery. Safety: the average postoperative CDVA of the observation group was better than that of the control group( P < 0. 05),and the safety index was 1. 14 in observation group and 1. 09 in the control group. The predictability was similar in both groups,but the stability of the observation group was a bit poor,without statistical difference( P > 0. 05). The higher-order aberrations,total difference,spherical and coma aberration in both groups at 2 years after operation were higher than those beforeoperation,but 6 mm pupil diameter inthe observation group was lower than that of the control group( P < 0. 05). The AMP improved at 0. 5,1,and 2 years after operation in the observation group while the AMP improved at 1 and 2 years postoperatively in the control group( P < 0. 05). The AMP was more quickly and greater in the observation group at three time pointsas compared with that of the control group( P < 0. 05). As for vaults,endothelial cell density and adverse events,both of the two groups showed similar results. Conclusion Application of ICL V4 c implantation for refractive errors has good effetiveness and safety in ametropia patients of 17-21 years old.
引文
[1]Sanders DR,Schneider D,Martin R,et al.Toric Implantable Collamer Lens for moderate to high myopic astigmatism[J].Ophthalmology,2007,114(1):54-61.
[2]Sanders DR,Doney K,Poco M.United states food and drug administration clinical trial of the implantable collamer Lens(ICL)for moderate to high myopia:three-year follow-up[J].Ophthalmology,2004,111(9):1683-1692.
[3]Shimizu K,Kamiya K,Igarashi A,et al.Early clinical outcomes of implantation of posterior chamber phakic intraocular lens with a central hole(Hole ICL)for moderate to high myopia[J].Br JOphthalmol,2012,96(3):409-412.
[4]Gomez-Bastar A,Jaimes M,Graue-Hernández EO,et al.Longterm refractive outcomes of posterior chamber phakic(spheric and toric implantable collamer lens)intraocular lens implantation[J].Int Ophthalmol,2014,34(3):583-590.
[5]Kamiya K,Shimizu K,Igarashi A,et al.Posterior chamber phakic intraocular lens implantation:comparative,multicentre study in351 eyes with low-to-moderate or high myopia[J].Br J Ophthalmol,2018,102(2):177-181.
[6]Tian Y,Jiang H,Jiang J,et al.Comparison of implantable collamer lens visian ICL V4 and ICL V4c for high myopia[J].Medicine,2017,96(25):7294-7299.
[7]Igarashi A,Kamiya K,Shimizu K,et al.Visual performance after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis for high myopia[J].Am J Ophthalmol,2009,148(1):164-170.
[8]Zhang J,Li JR,Chen ZD,et al.Phakic posterior chamber intraocular lens for unilateral high myopic amblyopia in Chinese pediatric patients[J].Int J Ophthalmol,2016,9(12):1790-1797.
[9]Lee J,Kim Y,Park S,et al.Long-term clinical results of posterior chamber phakic intraocular lens implantation to correct myopia[J].Clin Exp Ophthalmol,2016,44(6):481-487.
[10]Emara KE,Al Abdulsalam O,Al Habash A.Implantation of spherical and toric copolymer phackic intraocular lens to manage amblyopia due to anisometropic hyperopia and myopia in pediatric patients[J].J Cataract Refract Surg,2015,41(11):2458-2465.
[11]Kang M,Li S,Peng X,et al.Chinese eye exercises and myopia development in school age children:a nested case-control study[J].Sci Rep,2016,6(1):28531.
[12]Hasegawa A,Kojima T,Isogai N,et al.Astigmatism correction:laser in situ keratomileusis versus posterior chamber collagen copolymer toric phakic intraocular lens implantation[J].J Cataract Refract Surg,2012,38(4):574-581.
[13]Fujisawa K,Shimizu K,Uga S,et al.Changes in the crystalline lens resulting from insertion of a phakic IOL(ICL)into the porcine eye[J].Graefes Arch Clin Exp Ophthalmol,2007,245(1):114-122.
[14]Shiratani T,Shimizu K,Fujisawa K,et al.Crystalline lens changes in porcine eyes with implanted phakic IOL(ICL)with a central hole[J].Graefes Arch Clin Exp Ophthalmol,2008,246(5):719-728.
[15]Liu HT,Zhou Z,Luo WQ,et al.Comparison of optical quality after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis[J].Int J Ophthalmol,2018,11(4):656-661.
[16]Alfonso JF,Baamonde B,Fernandez-Vega L,et al.Posterior chamber collagen copolymer phakic intraocular lenses to correct myopia:five-year follow-up[J].J Cataract Refract Surg,2011,37(5):873-880.
[17]Naderi M,Sabour S,Khodakarim S,et al.Studying the factors related to refractive error regression after PRK surgery[J].BMCOphthalmol,2018,18(1):198.
[18]Igarashi A,Shimizu K,Kamiya K.Eight-year follow-up of posterior chamber phakic intraocular lens implantation for moderate to high myopia[J].Am J Ophthalmol,2014,157(3):532-539.
[19]Alfonso JF,Lisa C,Abdelhamid A,et al.Three-year follow-up of subjective vault following myopic implantable collamer lens implantation[J].Graefes Arch Clin Exp Ophthalmol,2010,248(12):1827-1835.
[20]Lee H,Kang DS,Ha B J,et al.Effect of Accommodation on Vaulting and Movement of Posterior Chamber Phakic Lenses in Eyes With Implantable Collamer Lenses[J].Am J Ophthalmol,2015,160(4):710-716.
[21]Yin ZQ,Wang H,Yu T,et al.Facilitation of amblyopia management by laser in situ keratomileusis in high anisometropic hyperopic and myopic children[J].J AAPOS,2007,11(6):571-576.
[22]Weakley DR,Lynn MJ,Dubois L,et al.Myopic shift 5 years after intraocular lens implantation in the infant aphakia treatment study[J].Ophthalmology,2017,124(6):822-827.
[23]马可,王琳,邱乐梅,等.高度近视眼有晶状体眼后房型人工晶状体植入术后调节功能变化[J].中国眼视光学与视觉科学杂志,2015,17(8):471-473.
[24]Kamiya K,Shimizu K,Aizawa D,et al.Time course of accommodation after implantable collamer lens implantation[J].Am J Ophthalmol,2008,146(5):674-678.
[25]Tychsen L,Faron N,Hoekel J.Phakic intraocular collamer lens(Visian ICL)implantation for correction of myopia in spectacleaversive special needs children[J].Am J Ophthalmol,2017,175:77-86.
[26]Kobashi H,Kamiya K,Igarashi A,et al.Long-term quality of life after posterior chamber phakic intraocular lens implantation and after wavefront-guided laser in situ keratomileusis for myopia[J].JCataract Refract Surg,2014,40(12):2019-2024.
[2]Sanders DR,Doney K,Poco M.United states food and drug administration clinical trial of the implantable collamer Lens(ICL)for moderate to high myopia:three-year follow-up[J].Ophthalmology,2004,111(9):1683-1692.
[3]Shimizu K,Kamiya K,Igarashi A,et al.Early clinical outcomes of implantation of posterior chamber phakic intraocular lens with a central hole(Hole ICL)for moderate to high myopia[J].Br JOphthalmol,2012,96(3):409-412.
[4]Gomez-Bastar A,Jaimes M,Graue-Hernández EO,et al.Longterm refractive outcomes of posterior chamber phakic(spheric and toric implantable collamer lens)intraocular lens implantation[J].Int Ophthalmol,2014,34(3):583-590.
[5]Kamiya K,Shimizu K,Igarashi A,et al.Posterior chamber phakic intraocular lens implantation:comparative,multicentre study in351 eyes with low-to-moderate or high myopia[J].Br J Ophthalmol,2018,102(2):177-181.
[6]Tian Y,Jiang H,Jiang J,et al.Comparison of implantable collamer lens visian ICL V4 and ICL V4c for high myopia[J].Medicine,2017,96(25):7294-7299.
[7]Igarashi A,Kamiya K,Shimizu K,et al.Visual performance after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis for high myopia[J].Am J Ophthalmol,2009,148(1):164-170.
[8]Zhang J,Li JR,Chen ZD,et al.Phakic posterior chamber intraocular lens for unilateral high myopic amblyopia in Chinese pediatric patients[J].Int J Ophthalmol,2016,9(12):1790-1797.
[9]Lee J,Kim Y,Park S,et al.Long-term clinical results of posterior chamber phakic intraocular lens implantation to correct myopia[J].Clin Exp Ophthalmol,2016,44(6):481-487.
[10]Emara KE,Al Abdulsalam O,Al Habash A.Implantation of spherical and toric copolymer phackic intraocular lens to manage amblyopia due to anisometropic hyperopia and myopia in pediatric patients[J].J Cataract Refract Surg,2015,41(11):2458-2465.
[11]Kang M,Li S,Peng X,et al.Chinese eye exercises and myopia development in school age children:a nested case-control study[J].Sci Rep,2016,6(1):28531.
[12]Hasegawa A,Kojima T,Isogai N,et al.Astigmatism correction:laser in situ keratomileusis versus posterior chamber collagen copolymer toric phakic intraocular lens implantation[J].J Cataract Refract Surg,2012,38(4):574-581.
[13]Fujisawa K,Shimizu K,Uga S,et al.Changes in the crystalline lens resulting from insertion of a phakic IOL(ICL)into the porcine eye[J].Graefes Arch Clin Exp Ophthalmol,2007,245(1):114-122.
[14]Shiratani T,Shimizu K,Fujisawa K,et al.Crystalline lens changes in porcine eyes with implanted phakic IOL(ICL)with a central hole[J].Graefes Arch Clin Exp Ophthalmol,2008,246(5):719-728.
[15]Liu HT,Zhou Z,Luo WQ,et al.Comparison of optical quality after implantable collamer lens implantation and wavefront-guided laser in situ keratomileusis[J].Int J Ophthalmol,2018,11(4):656-661.
[16]Alfonso JF,Baamonde B,Fernandez-Vega L,et al.Posterior chamber collagen copolymer phakic intraocular lenses to correct myopia:five-year follow-up[J].J Cataract Refract Surg,2011,37(5):873-880.
[17]Naderi M,Sabour S,Khodakarim S,et al.Studying the factors related to refractive error regression after PRK surgery[J].BMCOphthalmol,2018,18(1):198.
[18]Igarashi A,Shimizu K,Kamiya K.Eight-year follow-up of posterior chamber phakic intraocular lens implantation for moderate to high myopia[J].Am J Ophthalmol,2014,157(3):532-539.
[19]Alfonso JF,Lisa C,Abdelhamid A,et al.Three-year follow-up of subjective vault following myopic implantable collamer lens implantation[J].Graefes Arch Clin Exp Ophthalmol,2010,248(12):1827-1835.
[20]Lee H,Kang DS,Ha B J,et al.Effect of Accommodation on Vaulting and Movement of Posterior Chamber Phakic Lenses in Eyes With Implantable Collamer Lenses[J].Am J Ophthalmol,2015,160(4):710-716.
[21]Yin ZQ,Wang H,Yu T,et al.Facilitation of amblyopia management by laser in situ keratomileusis in high anisometropic hyperopic and myopic children[J].J AAPOS,2007,11(6):571-576.
[22]Weakley DR,Lynn MJ,Dubois L,et al.Myopic shift 5 years after intraocular lens implantation in the infant aphakia treatment study[J].Ophthalmology,2017,124(6):822-827.
[23]马可,王琳,邱乐梅,等.高度近视眼有晶状体眼后房型人工晶状体植入术后调节功能变化[J].中国眼视光学与视觉科学杂志,2015,17(8):471-473.
[24]Kamiya K,Shimizu K,Aizawa D,et al.Time course of accommodation after implantable collamer lens implantation[J].Am J Ophthalmol,2008,146(5):674-678.
[25]Tychsen L,Faron N,Hoekel J.Phakic intraocular collamer lens(Visian ICL)implantation for correction of myopia in spectacleaversive special needs children[J].Am J Ophthalmol,2017,175:77-86.
[26]Kobashi H,Kamiya K,Igarashi A,et al.Long-term quality of life after posterior chamber phakic intraocular lens implantation and after wavefront-guided laser in situ keratomileusis for myopia[J].JCataract Refract Surg,2014,40(12):2019-2024.