= 증례보고 = 두종류의삼체형비구면인공수정체삽입후임상결과의비교 대한안과학회지 2012 년제 53 권제 1 호 J Korean Ophthalmol Soc 2012;53(1):43-48 pissn: 0378-6471 eissn: 2092-9374 http://dx.doi.org/10.3341/jkos.2012.53.1.43 이준원 김재훈 김응권 김태임 연세대학교의과대학안과학교실, 시기능개발연구소 목적 : 두종류의삼체형비구면인공수정체삽입후임상결과를비교해보고자하였다. 대상과방법 : 백내장수술후두가지종류의삼체형비구면인공수정체인 TECNIS ZA9003 (1 군 ) 또는 HOYA PC-60AD (2 군 ) 을삽입한각 30 안, 28 안을대상으로술후 6 개월째나안시력, 최대교정시력, 고위수차및구면수차를포함한안구전체및안구내수차, 변조전달기능을평가하였고, 술전예측한목표굴절치와수술후실제구면대응치의차이를비교하였다. 결과 : 술후 6 개월에평가한나안시력과최대교정시력, 고위수차및구면수차를포함한안구전체및안구내수차, 변조전달기능은두군간에유의한차이를보이지않았다. 두인공수정체모두에서술전목표굴절치보다수술후근시쪽으로맞추어졌으며, 두군간의유의한차이는없었다 (-0.26 vs. -0.42diopter, p=0.75). 결론 : 새로개발된비구면인공수정체 HOYA PC-60AD 는기존에임상효과가검증된삼체형비구면인공수정체인 TECNIS ZA9003 와유사하게우수한임상적결과를보였다. < 대한안과학회지 2012;53(1):43-48> 현대적개념의백내장수술의목표는수술기법과인공수정체의발전을통해일차적인백내장의제거수준에서목표굴절치의정확한도달및시력의질향상까지고려하는방향으로발전하고있다. 1,2 젊었을때는양의구면수차값을가진각막에대해수정체가음의값을가짐으로써구면수차가서로상쇄되어비교적좋은시력의질을유지할수있으나, 나이듦에따라수정체가양의구면수차값으로증가함에따라시력의질이떨어진다. 3-6 따라서이전에사용되던양의구면수차값을가지는구면인공수정체는백내장수술후에도구면수차의증가가그대로유지되어눈부심, 빛번짐등의증상을야기하는반면에, 7,8 최근의비구면인공수정체는백내장수술후구면수차값을상쇄시켜시기능을향상시키는효과를보인다. 2,9-12 최초로개발된삼체형소수성아크릴접힘인공수정체는 AcrySof (Alcon Laboratories, Inc., Fort Worth, TX, USA) 로소수성광학부와 PMMA (polymethylmethacrylate) 로된지지부로만들어졌다. 이인공수정체는 1994년이후 접수일 : 2011년 2월 14일 심사통과일 : 2011년 8월 27일 게재허가일 : 2011년 10월 29일 책임저자 : 김태임서울시서대문구연세로 50 연세대학교세브란스병원안과 Tel: 02-2228-3570, Fax: 02-312-0541 E-mail: taeimkim@gmail.com 소개되어널리사용되고있으며, 안정적인임상결과로, 백내장수술발전에큰역할을하였다. 특히후낭에강력하게결합하여백내장수술후발생하는후낭혼탁을유의하게줄여성공적인임상결과를보이는데중요한영향을미쳤다. 13,14 여러삼체형인공수정체들이개발되어왔으며, 이후개발된일체형인공수정체와장기임상결과및안정성이큰차이가없이우수함이잘알려져있다. 15-17 TECNIS Acrylic IOL ZA9003 (AMO, Inc., Santa Ana, CA, USA) 인공수정체는비구면삼체형인공수정체로소수성아크릴재질로서전면부표면을변형시켜 -0.27 µm 의음의구면수차값을가지도록고안되었다. 현재까지가장널리쓰이는삼체형인공수정체중하나로많은이전연구에서우수한임상결과및안정성이증명되었다. 18-21 HOYA PC-60AD (HOYA CORPORATION, Tokyo, Japan) 인공수정체는최근소개된비구면삼체형인공수정체로소수성아크릴재질이며, 전면부표면을변형시켜 -0.18 µm의음의구면수차값을가진다. HOYA PC-60AD는인공수정체가주입기내에이미장착되어있는 preloaded injector system을특징으로하며, 인공수정체삽입이간편하고용이함을장점으로가지고있다. 두종류의삼체형인공수정체는 refractive index, 인공수정체의길이, 구면수차값에서약간의차이를보이는것이외에는많은점에서유사한특징을가지고있다 (Table 1). www.ophthalmology.org 43
- 대한안과학회지 2012 년제 53 권제 1 호 - Table 1. Optical characteristics of the aspherical IOLs used in this study Characteristics TECNIS ZA9003 HOYA PC60AD Optic type Monofocal Monofocal Lens 3-piece 3-piece Optical material Hydrophobic acrylate Hydrophobic acrylate Refractive index 1.47 1.52 Optic size (mm) 6 6 Overall length (mm) 13 12.5 Design Prolate anterior surface Prolate anterior surface Haptic angulation 5 5 Haptic material PMMA PMMA Sph A (µm) -0.27-0.18 IOLs = intraocular lens; PMMA = polymethylmethacrylate; Sph A = spherical aberration. 본연구는기존에널리쓰이고있는삼체형비구면인공수정체인 TECNIS ZA9003과새로개발된삼체형비구면인공수정체인 HOYA PC-60AD의술후나안시력, 최대교정시력및고위수차와구면수차를포함한안구전체및안구내수차, 변조전달기능 (modulation transfer function, MTF) 을비교하고자하였다. 또한각각의렌즈에서, 수술전 IOL master (Carl Zeiss, Jena, Germany) 로측정한술후목표굴절치와술후 6개월째실제굴절치를비교하여예측굴절치의정확도를비교하고자하였다. 대상과방법 2009년 12월부터 2010년 2월까지백내장초음파유화술및인공수정체안내삽입술을시행받은환자를대상으로무작위할당을통하여 TECNIS ZA9003을삽입군 (1 군 ) 과 HOYA PC-60AD 를삽입군 (2군), 두군으로분류하고전향적인연구를시행하였다. 각막난시가 2diopter 를넘지않는노인성백내장환자를대상으로하였고, 각막혼탁, 약시, 녹내장, 망막질환등눈에다른질환을가진사람과이전에굴절교정수술을받은사람및수술과정에서후낭파열등의합병증이발생한경우연구대상에서제외되었다. 수술전검사는모든환자에서 IOL master 를이용하여안축장및각막굴절력을측정하여인공수정체도수를구하였고, 목표굴절치는 SRK-T 공식을이용하여계산한값에서정시에가까운최소근시값으로하여이에적합한인공수정체도수를선택하여삽입하였다. 수술은단일술자에의해시행되었고, 점안마취후이측또는비측에 2.7 mm 투명각막절개를통해전방내점탄물질을주입한후 26 gauge의주사침을이용하여약 5.5 mm 크기의수정체낭원형절개를시행하였다. 평형염액을사용하여수력분리술및수력분층술을시행한후초음파를이용한수정체유화술로수정체핵을제거하였 으며관류흡입기로남아있는수정체피질을제거하였다. 그후카트리지를이용하여인공수정체를수정체낭내에삽입하였으며남아있던점탄물질을관류흡입기로제거하고평형염액을사용하여안구의긴장도를유지하였다. 모든환자는술후 6개월째현성굴절검사로구면대응치 (spherical equivalent, SE) 및원거리나안시력, 최대교정시력을측정하였다. 수차검사는산동된상태에서동공중심부 6 mm 영역에대해서시행되었다. itrace (Tracey Tech., Houston, TX, USA) 를사용하여 RMS (root mean square) 총합, 고위수차, 구면수차, 코마수차, 트레포일수차를각각측정하였고, 안구전체의수차 (total ocular aberration) 와각막수차를제외한안구내수차 (internal ocular aberration) 를나누어분석하였다. 또한 itrace 를사용하여 6mm 영역에서의변조전달기능 (modulation transfer function, MTF) 을측정하였다. 통계학적분석은통계프로그램 SPSS 12.0 for Windows (SPSS Inc., Chicago, IL, USA) 를사용하였으며, 통계학적유의성의기준은 p<0.05 로하였다. 두군간의수술후결과값의비교는 Student t-test 를이용하여분석하였다. 결과 환자군은총 58명 58안이었고, TECNIS ZA9003 을삽입한 1군 30안, HOYA PC-60AD를삽입한 2군 28안이었다. 연령, 성별등인구학적요인에서두군사이에유의한차이를보이지않았다 (Table 2). 수술후 6개월째측정한나안시력, 최대교정시력, 구면대응치는두군사이에유의한차이를보이지않았으며 (Table 3), 두군모두에서수술후 6개월까지경과관찰하였을때, 인공수정체기울어짐, 중심이탈등의인공수정체관련합병증은발생하지않았다. 술후 6개월째 Mydrin- P (Santen pharmaceutics, Tokyo, 44 www.ophthalmology.org
- 이준원외 : 두종류의삼체형인공수정체 - Table 2. Demographics of study groups TECNIS ZA9003 (Group 1) HOYA PC60AD (Group 2) No of eyes 30 28 OD:OS 16:14 14:14 Gender (M:F) 13:17 13:15 Age (mean ± SD, yr) 66.55 ± 11.16 68.89 ± 5.50 No = number; OD = right eye; OS = left eye; SD = standard deviation. Table 3. Visual acuity and refractive error at 6 months after operation Group 1 Group 2 p-value UCVA (log MAR) 0.12 ± 0.11 0.13 ± 0.10 0.68 BCSVA (log MAR) 0.00 ± 0.05 0.01 ± 0.05 0.45 Refractive error (SE) -0.57 ± 0.55-0.59 ± 0.40 0.62 Visual acuities are displayed as log MAR visual acuity. UCVA = uncorrected visual acuity; BCVA = best corrected visual acuity; SE = spherical equivalent. Table 4. Total ocular aberrations (μm) between the groups measured by itrace 6 months after operation IOL groups RMS HO A Sph A Coma Trefoil Group 1 1.04 ± 0.49 0.6 4± 0.34 0.06 ± 0.17 0.26 ± 0.22 0.34 ± 0.21 Group 2 1.09 ± 0.44 0.68 ± 0.26 0.16 ± 0.15 0.40 ± 0.24 0.30 ± 0.22 p-value 0.67 0.21 0.95 0.97 0.89 RMS = root mean square; HO A = higher-order aberration; Sph A = spherical aberration. Table 5. Internal aberration (μm) between the groups measured by itrace 6 months after operation IOL groups RMS HO A Sph A Coma Trefoil Group 1 1.07 ± 0.53 0.70 ± 0.35 0.14 ± 0.19 0.31 ± 0.23 0.30 ± 0.18 Group 2 1.16 ± 0.39 0.75 ± 0.28 0.09 ± 0.18 0.41 ± 0.27 0.24± 0.14 p-value 0.37 0.18 0.62 0.47 0.49 RMS = root mean square; HO A = higher-order aberration; Sph A = spherical aberration. Table 6. Comparison of modulation transfer function measured by itrace scan at 6 mm optic zone between the groups 6 months after operation Spatial frequency Group 1 Group 2 p-value 5 0.40 ± 0.14 0.35 ± 0.13 0.61 10 0.18 ± 0.08 0.13 ± 0.05 0.06 15 0.12 ± 0.05 0.10 ± 0.03 0.09 20 0.09 ± 0.04 0.07 ± 0.03 0.09 25 0.07 ± 0.03 0.06 ± 0.02 0.15 30 0.06 ± 0.02 0.04 ± 0.01 0.15 Table 7. Differences between postoperative refractive error and preoperative goal refractive error (calculated by IOL-master ) Group 1 Group 2 p-value Difference of refractive error (D) -0.26 ± 0.42-0.42 ± 0.37 0.75 D = diopter. Japan) 을이용하여 6 mm 이상의동공크기로산동한상태에서동공중심부 6mm 영역에대하여, itrace 로측정 한수차를비교한결과안구전체수차 (total ocular aberration) 및안구내수차 (internal ocular aberration) www.ophthalmology.org 45
- 대한안과학회지 2012 년제 53 권제 1 호 - 각각의 RMS 총합, 고위수차, 구면수차, 코마수차, 트레포일수차모두에서두군사이에유의한차이가발견되지않았다 (Table 4, 5). 동공크기 6 mm 영역에서 itrace 로측정한변조전달기능을비교한결과, 모든공간주파수영역에서두군사이에유의한차이가발견되지않았다 (Table 6). 수술전 IOL master 로측정한목표굴절치와술후 6 개월의실제굴절치의차이를비교하였는데수술후 6개월째, 1군의경우, 목표굴절치보다 -0.26 ± 0.42diopter (D) 만큼근시쪽으로맞추어졌으며, 2군의경우, 목표굴절치보다 -0.42 ± 0.37D만큼근시쪽으로맞추어졌다. 두군사이에술전목표굴절치와술후실제굴절치의차이는통계학적으로유의하지않았다 (-0.26 ± 0.42 vs. -0.42 ± 0.37D, p=0.75, Table 7). 술전목표굴절치와술후실제굴절치의차이의절대값의평균비교에서도두군사이에통계학적으로유의한결과를보이지않았다. (0.30 ± 0.38 vs. 0.45 ± 0.33D, p=0.39). 고찰 본연구에서는두삼체형비구면인공수정체사이의 6 개월째임상결과에대해비교하였다. 수술후 6개월째측정한모든시기능의결과에서유의한차이를보이지않았다. 수술후 6개월안구내구면수차는 1군은 -0.14 μm, 2군은 -0.09 μm으로측정되었으며, 이는두인공수정체모두에서기존에고안된 -0.27 μm, -0.18 μm보다적은값으로측정되었다. 수술후 6개월째굴절치는, 두인공수정체모두에서술전목표굴절치보다근시쪽으로맞추어졌으며, 그차이값은두군간에유의한차이를보이지는않았다. 나이가들면서시력의질적측면에서저하가오는것은고위수차특히그중구면수차의증가와관련이깊다. 특히백내장수술로수정체를제거하고삽입하는인공수정체의경우이런측면이고려되지않을경우구면수차의증가를초래하고이와같은구면수차는눈부심 (glare) 이나달무리 (halo) 를가져오거나대비감도 (contrast sensitivity) 저하를가져올수있다. 18-21 평균각막의구면수차값을 +0.27-0.28 μm 정도라고할때, 22,23 TECNIS ZA9003 인공수정체는 -0.27 μm의구면수차를갖고백내장수술후눈전체의구면수차를 0 μm으로만들고자계획되었다. HOYA PC-60AD 인공수정체는 -0.18 μm 인공수정체의구면수차를갖고, 시력이좋은젊은사람의평균구면수차인 +0.1 μm 정도를안구전체구면수차목표치로갖고있다. 24 본연구에서는술후안구내구면수차의경우, 1군은 -0.14 μm, 2군은 -0.09 μm으로측정되었다. 이값은본래의도했던값과다소차이가있으며, 두군모두에서의도된값보다적게측정되었고, 두군간에통계학적으로유의한차이는없었다. 또한, 다른고위수차값들모두에서두인공수정체사이에유의한차이를보이지않았다. 변조전달기능은시기능의평가를위한우수한재현성을가지는객관적지표로알려져있다. 25 가장이상적인시체계의경우, 공간주파수 0에서변조전달기능값은 1이된다. 공간주파수가증가할수록변조전달기능값은떨어지게된다. 본연구에서, 모든공간주파수에서변조전달기능값은두군사이에유의한차이를보이지않았다. HOYA PC-60AD 의 A-상수는 118.4이며, IOL master 에서 SRK-T 공식을사용할경우 118.6이다. TECNIS ZA9003의측정된 A-상수는 118.7이며, IOL-master 에서 SRK-T 공식을사용할경우 119.1이다. 본연구의대상이된환자의경우술전에모두 IOL master 를이용하여각막굴절률과안축장의길이를측정하였으며, 기계에내재되어있는 SRK-T 공식을이용하여, 목표굴절치를계산한후이를근거로정시에가까운최소근시값을목표로인공수정체도수를선택하여삽입하였다. 본연구결과상 6개월째두인공수정체모두에서의도했던것보다근시로맞추어졌다. 두군간에유의한차이를보이지는않았지만, 2군의경우 -0.42D만큼근시로맞추어졌다. 예상한것보다근시쪽으로이동한측면은원시가되는것보다는좀더나을수있으나백내장수술을통해굴절이상의최소화를꾀하고있는최근백내장수술의경향을고려할때이러한차이는최소화하는것이바람직하겠다. 따라서본연구를통해얻어진결과를바탕으로같은수술환경에서 HOYA PC-60AD 를사용하는경우에는, A-상수값을조정하거나목표굴절치가 0.42D만큼덜근시인인공수정체를선택할수있을것이다. 본연구에서는최근소개된삼체형소수성아크릴비구면인공수정체인 HOYA PC-60AD 의임상적결과를기존에널리쓰이는 TECNIS ZA9003과비교하였는데두인공수정체는매우유사한특성을가진다 (Table 1). 본연구를통해저자들은백내장수술 6개월후의임상결과에서두인공수정체가유사한임상결과를보임을증명하였는데, 이는새로개발된삼체형인공수정체를소개하였을뿐아니라, 국내외연구에서 HOYA PC-60AD 의임상결과에대해처음으로보고한것이다. 결론적으로, 본전향적연구에서, 새로개발된비구면인공수정체 HOYA PC-60AD 는기존에임상결과가검증된삼체형비구면인공수정체 TECNIS ZA9003와유 46 www.ophthalmology.org
- 이준원외 : 두종류의삼체형인공수정체 - 사하게우수한임상적결과를보임을확인하였다. 참고문헌 1) Werner L, Olson RJ, Mamalis N. New technology IOL optics. Ophthalmol Clin North Am 2006;19:469-83. 2) Holladay JT, Piers PA, Koranyi G, et al. A new intraocular lens design to reduce spherical aberration of pseudophakic eyes. J Refract Surg 2002;18:683-91. 3) McLellan JS, Marcos S, Burns SA. Age-related changes in monochromatic wave aberrations of the human eye. Invest Ophthalmol Vis Sci 2001;42:1390-5. 4) Oshika T, Klyce SD, Applegate RA, Howland HC. Changes in corneal wavefront aberrations with aging. Invest Ophthalmol Vis Sci 1999;40:1351-5. 5) Artal P, Guirao A, Berrio E, Williams DR. Compensation of corneal aberrations by the internal optics in the human eye. J Vis 2001;1:1-8. 6) Applegate RA, Howland HC, Sharp RP, et al. Corneal aberrations and visual performance after radial keratotomy. J Refract Surg 1998;14:397-407. 7) Rawer R, Stork W, Spraul CW, Lingenfelder C. Imaging quality of intraocular lenses. J Cataract Refract Surg 2005;31:1618-31. 8) Guirao A, Redondo M, Geraghty E, et al. Corneal optical aberrations and retinal image quality in patients in whom monofocal intraocular lenses were implanted. Arch Ophthalmol 2002;120: 1143-51. 9) Altmann GE, Nichamin LD, Lane SS, Pepose JS. Optical performance of 3 intraocular lens designs in the presence of decentration. J Cataract Refract Surg 2005;31:574-85. 10) Caporossi A, Martone G, Casprini F, Rapisarda L. Prospective randomized study of clinical performance of 3 aspheric and 2 spherical intraocular lenses in 250 eyes. J Refract Surg 2007; 23:639-48. 11) Mester U, Dillinger P, Anterist N. Impact of a modified optic design on visual function: clinical comparative study. J Cataract Refract Surg 2003;29:652-60. 12) Ahn HS, Kim SW, Kim EK, Kim TI. Wavefront and visual function analysis after aspherical and spherical intraocular lenses implantation. J Korean Ophthalmol Soc 2008;49:1248-55. 13) Oshika T, Nagata T, Ishii Y. Adhesion of lens capsule to intraocular lenses of polymethylmethacrylate, silicone, and acrylic foldable materials: an experimental study. Br J Ophthalmol 1998;82:549-53. 14) Versura P, Torreggiani A, Cellini M, Caramazza R. Adhesion mechanisms of human lens epithelial cells on 4 intraocular lens materials. J Cataract Refract Surg 1999;25:527-33. 15) Nejima R, Miyata K, Honbou M, et al. A prospective, randomised comparison of single and three piece acrylic foldable intraocular lenses. Br J Ophthalmol 2004;88:746-9. 16) Hayashi K, Hayashi H. Comparison of the stability of 1-piece and 3-piece acrylic intraocular lenses in the lens capsule. J Cataract Refract Surg 2005;31:337-42. 17) Son SW, Seo JW, Shin SJ, Chung SK. Comparison of the stability between three-piece and single-piece aspheric intraocular lenses. J Korean Ophthalmol Soc 2010;51:1584-9. 18) Ohtani S, Miyata K, Samejima T, et al. Intraindividual comparison of aspherical and spherical intraocular lenses of same material and platform. Ophthalmology 2009;116:896-901. 19) Yamaguchi T, Negishi K, Ono T, et al. Feasibility of spherical aberration correction with aspheric intraocular lenses in cataract surgery based on individual pupil diameter. J Cataract Refract Surg 2009;35:1725-33. 20) Kim SW, Ahn H, Kim EK, Kim TI. Comparison of higher order aberrations in eyes with aspherical or spherical intraocular lenses. Eye (Lond) 2008;22:1493-8. 21) Takeo S, Watanabe Y, Suzuki M, Kadonosono K. Wavefront analysis of acrylic spherical and aspherical intraocular lenses. Jpn J Ophthalmol 2008;52:250-4. 22) Wang L, Dai E, Koch DD, Nathoo A. Optical aberrations of the human anterior cornea. J Cataract Refract Surg 2003;29:1514-21. 23) Beiko GH, Haigis W, Steinmueller A. Distribution of corneal spherical aberration in a comprehensive ophthalmology practice and whether keratometry can predict aberration values. J Cataract Refract Surg 2007;33:848-58. 24) Levy Y, Segal O, Avni I, Zadok D. Ocular higher-order aberrations in eyes with supernormal vision. Am J Ophthalmol 2005;139:225-8. 25) Norrby NE, Grossman LW, Geraghty EP, et al. Determining the imaging quality of intraocular lenses. J Cataract Refract Surg 1998;24:703-14. www.ophthalmology.org 47
- 대한안과학회지 2012 년제 53 권제 1 호 - =ABSTRACT= Comparative Study of Clinical Outcomes between 2 Types of 3-Piece Aspheric Intraocular Lenses Junwon Lee, MD, Jae Hun Kim, MD, Eung Kweon Kim, MD, PhD, Tae Im Kim, MD, PhD Department of Ophthalmology and The Institute of Vision Research, Yonsei University College of Medicine, Seoul, Korea Purpose: To compare postoperative clinical outcomes between 2 types of 3-piece aspheric intraocular lenses. Methods: Uncorrected visual acuity, best corrected visual acuity, total ocular and internal ocular aberration including higher-order aberrations and spherical aberration, and modulation transfer functions were compared 6 months after cataract surgery between eyes implanted with TECNIS ZA9003 (group 1) and HOYA PC-60AD (group 2) in 30 and 28 eyes, respectively, In addition, the differences between postoperative spherical equivalent and preoperative target refractive errors were analyzed. Results: Clinical outcomes showed no significant differences between both groups including visual acuities, high order aberrations, and modulation transfer function. In both groups, postoperative refractive errors were more of a myopic state than preoperative estimated target refraction. The myopic refractive error between both groups showed no significant difference (-0.26 vs. -0.42 diopter, p = 0.75). Conclusions: The newly developed 3-piece aspheric IOL, HOYA PC-60AD shows similar clinical outcomes compared with the widely used 3-piece IOL TECNIS ZA9003. J Korean Ophthalmol Soc 2012;53(1):43-48 Key Words: High order aberration, Modulation transfer function, Spherical aberration, 3-piece intraocular lens Address reprint requests to Tae Im Kim, MD, PhD Department of Ophthalmology, Yonsei University Severance Hospital #50 Yonsei-ro, Seodaemun-gu, Seoul 120-752, Korea Tel: 82-2-2228-3570, Fax: 82-2-312-0541, E-mail: taeimkim@gmail.com 48 www.ophthalmology.org