バルベルト 緑内障 インプラントの適正使用について
Contents
1.2. 8 xyr pn
3. 1
4. 1 3 2
5. 4 QMS 14 6
6. 9 10 1 23 2
7. 1
8. 1 2 23 7 25 1
9. IOP 21mmHzs JIS T 14971 AM
10. 200mm 350 mm BG 101 350 1990 IDE G890233 FDA 10 k BG 102 350 1995 1997 FDA 10 k IDE G890233 GCP 1995 GCP
11. 1 2 2 2 0 8 3 1
12. UL gt 0 9N 103kPa 0 10L min 0 15L min 0 1 BG 101 350 BG 103 250 7
13. 2 3 2 3 4 8
14. 0 0 0 gs
15. 14 15 16 5 6 2
16. World Glaucoma Association WGA 11 1 200mm 350 mm BG 101 350 1990 5 1990 9 lt
17. ISO 11979 6 2002 Ophthalmic implants Intraocular lenses Part 6 Shelf life and transport stability G J I 4 EE II 1 0 2 1N gt 0 9N 1 1 EE EEE ESE 3
18. 20 0 lt 2
19. 3 21
20. 2
21. 2 Nmm
22. 7 8 9 10 Oo 11 12 13
23. 1 105 0001 5 13 1 03 5402 8900 mA AMO Groningen BV 23 7 23 04 22 3 31 23 7 25 04
24. 4 18 TVT 1 0799 4 95 3 101 107 TVT 1 3 4 8 iv 2 80 3 107 11 1 12 108 7 21 8 12 33 9 4 17 1724 10 3 13 17
25. 2000 2002 40 5 0 B
26. 1 2 23 3
27. 1 2 0 2 Skg 10 10 BG 103 250 4 6mm 1 3 1 2 4 8 12 16 20 24 1 1 2 4 8 12 24 2 4 8 12 24 2
28. 250mm 350mm 2 3
29. 13 13 19 22 33 33 6 NN NA 15 4 23 1 7 69 16 7 QOP 4
30. 22 3 31 FDA IDE
31. 4 5 6 BG 102 350 1 1 3 5 2 3 2 1
32. 4 JMDN 36099000 BG 101 350 BG 103 250 BG 102 350 1 1 2 3 4 5 6 2 1 2 Oot 4 oe te 1 4 BG 101 350 BG 103 250 BG 102 350 sr BG 101 350 BG 102 350 31 1 14 7 9 102 7mm 5 3mm 2 ee UN PT 3
33. 10 6 17 91 11 12 83 10712 42 5 12 17 2712 8 1712 3 3 1 1 O 2 45C 2 6 4 2 ee 0 E Na 2
34. 0O 1 BG 102 350 10 14 gt 0 9N b ISO 10993 5 1993 USP lt 87 gt 1995 ISO 10993 1
35. 6 1 Wright Medical 1991 310 k Pharmacia 1997 Pharmacia CE Pfizer 2004 Advanced Medical Optics Inc Abbott Medical Optic nc AMO
36. BG 102 350 ee PT 1 1 BG 102 330 BG 103 230 BG 101 350 3 20 12 25 20 8 5
37. 1 2 3 4 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
38. C 3 IOP 20 IOP gt 21mmHg IOP SmmHg 86 1 31 36 70 0 14 20 5 FU MMC 100 15 15 MMC 71 4 10 14 p 0 4 NVG non NVG NVG 33 3 12734 non NVG 14 7 11 74 we 5 4
39. mmHg 4 mms 1 1 1 6 7 1 G Gi Gv 4 2 4 8 12 24 BG 103 250
40. 0 OR 7 18 19 3 2 IDE G890233
41. 83 3 10 12 BG 102 330 16 7 2 12 8 33 1 12 8 33 1 12 8 33 1 12 8 33 1 12 8 33 1 12 22 9 09 2722 4 54 1 22 4 54 1722 4 54 1722 4 54 1722 4 54 1 22 4 54 1 22 2 BG 102 350 IOP 21mmHg IOP 21mmHg IOP 21mmHg 58 3 7 12 33 3 4 12 0 0 12 8 33 1 12 IOP 22 80mmHg 2 5 9 20mmHg 0 5 83 3 10 12 16 7 2 12 0 0 12 8 33 1712 8 33 1 12 0 10 0 0
42. 2 3 4 5 7 6 1 1
43. 200mm Molteno Molteno 200mm 2 6 1 8 12 5 12 12 IOP IOP 3 IIOP 21 mmHg
44. 2 7 20 21 20 21 6mmHg IOP 21mmHg 2 20 IOP SmmHg lt IOP 22mmHg 7 20 MD 6mmHg lt IOP 22mmHg IOP 22mmHg 6 IOP 1 77 92 2 66 85 3 64 73 4 64 59 3 44
45. Ahmed 1 73 83 2 62 75 3 62 71 4 62 1 0 1 2
46. IO 1991 2 1997 2 310 k 1997 8 CE 2011 6 AMO 2004 2011 6
47. 1 Rauscher FM Gedde SJ Schitfman JC et al Mobihty disturbances in the tube Versus trabeculectomy study durmg the frst year of folloWw up Am J Ophthalmol 2009 147 458 466 Ahmed S2 250mm oulet R J Phan A D T et al Efficacy of the Ahmed S2 glaucoma valve compared with the Baerveldt 250 mm glaucoma implant Opthalmology 2008 115 1141 1147 1 edde S J Schiffman J C et all Tretment outcomes in the tube Versus trabeculectomy study after one year of follow up Am J Ophthalmol 2007 143 9 22 1 edde S J Herndon L W et all Surgical comphcations in the tube versus trabeculectomy study durmg the first year of follow up Am J Ophthalmol 2007 143 23 31 250mm2 WuDunn D Phan A D et al Clinical experience with the Baerveldt 250 mm2 glauc oma implant Ophthalmology 2006 113 766 772 Mmckler D S Vedula S S et al Aqueous shunts for glaucoma Cochrane
48. 3 1 2
49. 3 10 1Spsi 103kPa 0 13L min 103kPa 0 10 0 1SL min
50. 2 41 3 41 3 17 122 16 169 41 3 CZ a FDA 1998 11 16 Agueous Shunts 10 k Submissions BG 102 350
51. AMO 2004 2011 6 0mmHg 8 1 1 4 1 1 1 1 1 IDE ISO10993 1 ISO11137
52. Ne SU CO 0 AN NN 2 2 250mm7 350mm 2 17 3 212 1 3 4 8 iv TVT TVT
53. 3 NN 1990 5 8 1 II ye 12 699 9718 92 12 13 89 1 13 22 3 13 15 2 13 8 1 13 1990 9 1994 6 12
54. 200mm 350mm BG 101 350 IDE G890233 200mm 250mm BG 103 250 1990 5 1990 9 12 22 Molteno BG 101 350 encircling element Molteno
55. 8 33 1 12 8 33 1 12 8 33 1 12 0 0 12 0 0 0 0 22 BG 102 350 12 3 21 21 1 2004 2009 Medline Biosis Previews BMbase SciSearch 15 Baerveldt glaucoma shunt pars plana model 250 model 350 22 4 12 15 4 16 19 14 3 3 14
56. IIOP 21 mmHg IOP gt 21 mmHg IOP 40 IOP 14 5 2 5mmHg TOP 20mmHg 13 BG 101 350 10 200mm 3 12 1 6 8 12 1 6 8 63 7 28 95 10 2 1 IOP 33mmHg 14 70 mmHg
57. 2 5 1 2 3 QOL 2
58. 22 22 IOP 47 1SmmHg 22 80 mmHg 22 BG 102 350 12 8 4 8 3 12 4 2 6 12 IOP 48 19mmHg 22 80 mmHg 1 3 1 6 6 50 16 BG 102 350 6 17
59. IOP 2 12 1 6 21 mmHg 69 2 9713 30 8 4 13 38 5 5 13 23 1 3 13 7 69 1 13 92 3 12 13 1 11 13 1 13 99 7 69 1 23 1 3 15 4 2 7 69 1 1 1 IDE G890233 30 8 4 13 38 5 5 13 23 1 3 13 7 69 1713 92 3 1 2 o a 23 1 3 13
60. 69 3 6 12 91 6 6 17
61. BG 102 350 BG 101 330 500mm Molteno single plate 4 44 22 BG 102 330 12 BG 101 350 6 00mm 2 Molteno single plate 2 22 13 9 13 6 22 6 4 12 22 IOP
62. 0 8 3 1 1 08 3 1 4 08 3 1 1 23 8 3 1 2 2 22300BZX 00370000 2 3 8 3 9 MY
63. 2 http www nichigan or jp member guideline glaucoma2 jsp R Rand Alhngham Karim F Damjl Sharon Freedman Sayoko E Moroi George ShafranoV Shields Textbook of Glaucoma Fifth Edition LIPPINCOTT WILLIAMS amp WILKINS 2005 610 625 7 The Advanced Glaucoma Intervention Study AGIS 7 The relationship between control of Intraocular pressure and visual field deterioration The AGIS Investigators Am J Ophthalmol 2000 130 429 440 11 2010 pp 84 2D Broadway I Grierson and R Hitchings Racial differences in the results of glaucomafiltration surgery are racial differences in thecon unctival cell profile important Br J Ophthalmol 1994 78 466 475 24 2 3 8 10 4 22 3 81 28 8 10
64. 7 69 1 13 15 4 2713 10 13 Molteno 13 6 80 0 8 10 Molteno 63 4 26 41 200mm BG 101 350 3 BG 101 330 2 BG 102 350 BG 102 350 1990 1994 2
65. 04 22 3 31 2 amp PPM see 7 gt 0OD uh eee 2 BG 103 250 BG 101 350
66. 2 0 8 3 1 5 0 8 3 1 2 2 3 8 3 1 2 3 6 9 22300BZX00370000 0 8 3 1 3 0 8 3 1 6 0 8 3 1 3 2 3 8 3 1 2
67. 10 IOP IOP 3 IOP 21 mmHsg 14 IOP 21 mmHg IOP gt 21 mmHg IOP BG 102 330 12 22 80 mmHg 9 20 mmHg 22 22 80 mmHg 9 21 mmHg BG 102 350 58 3 7712 33 3 4 12 0 0 12 8 33 1 12 2 5 0 5
68. 0 1995 USP lt 88 gt Class V 1995 ASTM F2147 2001 ISO 10993 3 1993 ISO 10993 6 1993 USP lt 88 gt Class V 1995 1994 SO 10993 SO 10993 10 ISO 10993 3 ISO 10993 6 10 11 USP lt 88 gt ClassVI 1994 USP lt 87 gt Class VD USP lt 88 gt Class VI USP lt 88 gt Class VD 1996 USP lt 87 gt 199 USP lt 88 gt Class VI AMO ISO 10993 1 2003 FDA ISO 10993 1 2003
69. 3 84 9 69 3 60 39 6 NRR 1055 13 1153
70. 3 1 38 43 Ahmed Baerveldt Tsal J C Johnson C C et al 2 0IThe Ahmed shunt versus the Baerveldt shunt for refractory glaucoma II Longer term outcomes from a single surgeon Ophthalmology 2006 113 913 917 C Baerveldt Irak 1 Moster M R and Fontanarosa J Intermediate term results of Baerveldt tube shunt surgery with mitomycm C use Ophthalmic Surgery Laser amp Imagmg 2004 35 189 196 TVT 3 Gedde S J Schiffman J C et al Three year follow up of the tube versus trabeculectomy study American Jounal of Ophthalmol 2009 148 670 684 1 iv
71. 32 21 4 69 3 64 1 2 3 1 2
72. database of systematic reviews England 2006 2 pCD004918 Baerveldt van Overdam K A de Faber J T HLN et al Baerveldt glaucoma nmplant m paediatric Datients British Journal of Ophthalmology 2006 90 3 328 32 TVT Gedde S J Schiffman J C et al The tube versus trabeculectomy study design and baseline characteristics of study patients American Journal of Ophthalmology 2005 140 2 275 287 Baerveldt Ahmed Wang J C See J L S et al Experience with the use of Baerveldt and Ahmed glaucoma drainage implants in an Asian population Ophthalmology 2004 111 7 1383 8 Chung A N Aung T et al Surgical outcomes of combmed phacoemulsitication and glaucoma dranage nmplant surgery for Asian patients with refractory glaucoma with cataract American Journal of Ophthalmology 2004 137 2 294 300 16 350 Ahmed Syed Hasan M Law Simon K et al Baerveldt 350 implant versus Ahmed valve for refractory glaucoma a case controlled comparison Journal of laucoma 2004 1
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