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Antonio M. Fea, 1 Andrea Gilardi, 1 Davide Bovone, 1 Michele Reibaldi, 1 Alessandro Rossi, 1 Earl R. Craven21 Diploma ye Scientific Ophthalmological University of Turin, Turin, Italy;2 Johns Hopkins University, Baltimore, Maryland, USA Elmer Eye Institute Glaucoma Centre of Excellence Umbhali ohambelanayo: Antonio M. Fea, +39 3495601674, i-imeyile [i-imeyile ekhuselweyo] Abstract: PRESERFLO™ MicroShunt sisixhobo esitsha sotyando lweglaucoma oluncinci (MIGS) ) ifakwe kwi-ab yangaphandle, i-aqueous humor ikhutshelwa kwindawo engaphantsi kwe-conjunctival.Kuye kwaphuhliswa njengonyango olukhuselekileyo nolungaphantsi konyango lwezigulane ezine-glaucoma evulekileyo ye-open-angle (POAG) engalawulwayo ngokwamayeza.Indlela yeklasi yokufakelwa kwe-MicroShunt ibandakanya amanyathelo ahlukeneyo abalulekileyo, kubandakanywa ukudala ipokotho encinci ye-scleral ene-1mm blade, ukufaka inaliti ye-25G (25G) ngepokotho ye-scleral kwigumbi langaphambili (AC), kunye nodonga oluncinci lwe-23-gauge. 23G ) I-cannula igubha i-stent.Nangona kunjalo, ukufakwa kwenaliti kwi-pocket scleral kudala umjelo ongalunganga, okwenza kube nzima ukuthunga isixhobo.Injongo yeli nqaku kukuphakamisa indlela eyenziwe lula yofakelo.Indlela yethu iphakamisa ukwenza i-tunnel ye-scleral usebenzisa inaliti ye-25G ngokuthe ngqo kunye nokusebenzisa le inaliti ye-25G kwi-limbus ukutyhala kancane i-sclera kwi-AC.Emva koko i-MicroShunt yahlanganiswa kwi-cannula ye-23G eyayifakwe kwi-syringe ye-1ml.Isixhobo sinokugungiswa ngesirinji.Ngaloo ndlela, ukuphuma kwamanzi kunokuqinisekiswa ngokukhawuleza ngokujonga amaconsi amanzi aphuma kwiindawo ezingaphandle ze-stent.Le ndlela entsha ingaba neenzuzo ezahlukeneyo ezinokuthi zibe nokulawulwa okungcono kwendawo yokungena, ukuphepha iipaseji zobuxoki, ukunciphisa okanye ukupheliswa komngcipheko wokuphuma kwecala lokuhleka kwamanzi, ukukhuthazwa kwendlela ehambelanayo kwindiza ye-iris, kunye nesantya esikhulu.Amagama angundoqo: I-MIGS, i-glaucoma evulekile, i-Preserflo, i-MicroShunt, utyando lwe-glaucoma, ukuhluzwa kwe-subconjunctival.
Kwiminyaka embalwa edlulileyo, utyando oluncinci okanye oluncinci (MIGS) luye lwavela kwintsimi yotyando lwe-glaucoma.I-1-5 Ezi zixhobo ze-MIGS zenzelwe unyango lwezigulane ezingajongwanga zonyango kunye ne-primary open-angle glaucoma (POAG) ukuphucula ukhuseleko ngelixa kugcinwa ukusebenza kokunciphisa uxinzelelo lwe-intraocular (IOP).Izixhobo ze-1-5 ze-MIGS zinokuhlulwa zibe: trabecular, suprachoroidal, kunye ne-subconjunctival.I-1,3 i-Subconjunctival outflow ixelisa indlela ye-trabeculectomy.Xa kuthelekiswa ne-trabeculectomy, inikezela ngoxinzelelo oluphantsi lwe-postoperative intraocular, ibonelela ngeenkqubo ezisemgangathweni kunye nokhuseleko olukhulu.I-1-5 Zonke izixhobo ze-subconjunctival zisekelwe kwi-tubule implantation.Imilinganiselo yelumen yezi zixhobo iqikelelwe kusetyenziswa iHagen-Poiseuille laminar flow equation.1 Ngokuqhelekileyo, i-lumen ikhethwa ukukhusela i-hypotension engapheliyo kwaye inkulu ngokwaneleyo ukuphepha ukuvalelwa.
Nangona kukho ingxoxo malunga nokuqwalasela i-MicroShunt njenge-MIGS, ngeenjongo zolu xwebhu, igama elithi MIGS liya kusetyenziswa kulo.I-Preserflo TM i-MicroShunt implant isanda kuqaliswa.I-6 I-shunt iqukethe ibhloko ye-polystyrene, ibhloko ye-isobutylene, i-polymer ye-styrene eyayisetyenziswa ngaphambili njenge-coronary stent kuba ibangela ukuvuvukala okuncinci kunye ne-encapsulation.I-7,8 Isixhobo si-8.5 mm ubude kwaye sine-lumen ye-70 µm ukulawula ukuhamba nokugcina i-IOP ngaphezu kwe-5 mmHg.(ngomlinganiselo wemveliso yamanzi).I-8 Ubude besixhobo buvumela ukuphuma kwamanzi amaninzi angasemva, ngoko ke umgca obanzi ongasemva uyacetyiswa.
Ngokuqhelekileyo, i-oblique quadrant yindawo ekhethiweyo yokufakelwa njengoko igwema ukufikelela kwi-rectus muscle ephezulu.Ugxininiso lwe-Mitomycin-C (MMC) kunye namaxesha okuvezwa ahluka ngokuxhomekeke kwizinto ezinobungozi okanye amava kagqirha.9-16
Olu qwalaselo lufutshane lujolise ekuchazeni uhlengahlengiso olongezelelweyo kwinkqubo yokufakelwa kweMicroShunt ngokukhawuleza nangokulula.
Ukuphononongwa kweerekhodi zonyango kuvunywe yiKomiti yezokuziphatha yeYunivesithi yaseTurin.Ngenxa yokuba oku kwakujongwa kwakhona kwiirekhodi zonyango, ikomiti yezokuziphatha yalahla imfuneko yokufumana imvume ebhaliweyo enolwazi lokuthatha inxaxheba kuphononongo.Nangona kunjalo, bonke abathathi-nxaxheba banikezela imvume ebhaliweyo ngaphambi kokuhlinzwa.
Ukuqinisekisa ubumfihlo besigulane, ulwazi lwabo aluchazwanga ngokusetyenziswa kwezinto zokufanisa ezizodwa.Iprothokholi yokufunda ilandele imigaqo yeSibhengezo saseHelsinki kunye neZikhokelo zokuSebenza okuLungileyo kweKlinikhi / iKomiti yoLungelelaniso lwamazwe ngamazwe.
Uphononongo lwangoku lubandakanya izigulane ze-POAG ezilandelelanayo ≥iminyaka eyi-18 ubudala kunye nezigulane eziphathwe ngamachiza kunye ne-IOP yangaphambili ye-IOP ≥23 mmHg eyaye yafakelwa ngokuzimeleyo kwe-MicroShunt.
I-PRESERFLO TM I-MicroShunt (i-Santen ex Innfocus, i-Miami, i-FL, i-USA) inikezelwa kwikiti yokupakisha eyinyumba equkethe i-3 mm scleral marker, i-1 mm ye-triangular blade, 3 LASIK Shields TM (EYETEC, Antwerp, Belgium), umakisha kunye nobukhulu be-25. inaliti (25G).
Ngaphambi kokusebenzisa i-MicroShunt, umenzi uncoma ukugcwalisa kwakhona nge-cannula ye-23G, engabandakanywa kwikiti.
Nangona idibanisa ukuba oogqirha be-glaucoma baqhelene nenkqubo yokufakelwa kweklasikhi, amanye amanyathelo anokuba ngumngeni.Ngokukodwa, xa inaliti ye-25G iphosa, i-tip yayo inokwenza ishaneli engafanelekanga / engafanelekanga kwindiza eyahlukileyo okanye ingene kwigumbi langaphambili ngaphandle kokufikelela phezulu kwi-tunnel ye-scleral.Kunzima ngokwenene ukulawula indlela yenaliti ye-25G kuba indawo engaphakathi kwi-tunnel ye-scleral iyinyani, okanye ubuncinci kakhulu (jonga umfanekiso 1).
Umzobo 1. Isishwankathelo sezigaba eziphambili zendlela entsha yotyando.(A) Inaliti yenzelwe ukungena kwi-sclera 3 mm ukusuka kumda.(B) Nje ukuba inaliti ifikelele kwilungu, ityhilwa phantsi.(C) Inaliti ingena kwigumbi elingaphambili.(D) Emva kokudala i-tunnel ene-triangular blade, indlela yenaliti esetyenziselwa ukungena kwigumbi langaphambili ayinakulandela i-tunnel, idala i-passage yobuxoki.
Kwezinye iimeko, le ngxaki inokwenza ukufaka i-microshunt kwigumbi langaphambili (AC) kube nzima kuba incam yayo ivaliwe kwitonela.Ukongeza, oku kuguqulwa kunokuba nzima ngakumbi emehlweni ane-limbal anatomy engaqhelekanga.
Kwakhona, ukuba iinzame zesibini zisasilela, ugqirha unokunyanzelwa ukuba afakele isixhobo ngendlela enenzuzo ngakumbi.Esi siza sithambekele ngakumbi kwimivalo elandelayo ngenxa yobukho be-rectus abdominis ephezulu.
Ukunqanda le ngxaki, enye inketho kukufaka i-AK ngencam ye-microknife esetyenziselwa ukwenza ipokotho ye-sclera.Ngelixa le ndlela igcina ixesha kwaye ikhusela ukudalwa kwemihlathi ephosakeleyo, kunokuba nzima ukuqikelela ubude be-AC engenayo.Ukongezelela, i-triangular shape ye-blade ichaza indlela enkulu, eyenza i-lateral flow in the early postoperative period.Ngokomthetho kaPoiseuille, ukuhamba kwecala kuphinda kuthintele iinzame zokudala ukuphuma kwamanzi anikezelweyo ukusuka kwi-AC, enokuthi ibe negalelo ekuphuhliseni i-hypotension.
Ubuchwephesha bethu botyando bubonelela ngophuculo kabini kuneenkqubo zotyando zesintu.Eyokuqala kukusebenzisa ngqo inaliti ye-25G njengetonela.Njengophuculo lwesibini, ubuchule bethu buphakamisa ukubamba i-cannula ye-23G, eqhele ukusetyenziswa kwi-oyile ye-silicone aspiration, ukuya ekupheleni kwe-MicroShunt.Ngaloo ndlela, ugqirha unokucoca isixhobo ngokuthe ngqo ngexesha lokufakwa kwentambo.
Ukusebenzisa inaliti ye-25G ukwenza i-tunnel yenza lula inkqubo yotyando njengoko iphelisa imfuno ye-pocket scleral kwaye inciphisa kakhulu indawo ye-scleral echaphazelekayo kwinkqubo.Ukongezelela, olu phuculo lunceda ukunciphisa umonakalo onokwenzeka kwixesha elide kwiiseli ze-endothelial ngokucinezela i-sclera njengoko isondela kwi-limbus, ngaloo ndlela ingena kwi-iris kwindiza ehamba phambili (jonga uMfanekiso 1 kunye nevidiyo eyongezelelweyo).
Uphuculo lwesibini olunikezelwa yiteknoloji entsha kukusetyenziswa kwe-cannula ye-23 G, efana ne-cannula esetyenziswa ngokuqhelekileyo kwi-oyile ye-silicone aspiration.Le cannula ye-23G ilungisa ngokugqibeleleyo iMicroShunt kwaye yenza kube lula ukuyigungxula.Ukongezelela, i-fluid efakwe kwi-AC iphinda ikhulise uxinzelelo, ivumela i-aqueous humor ukuba ihambe kwi-distal end yesixhobo (jonga uMzobo 1 kunye nevidiyo eyongezelelweyo).
Amava ethu ekliniki aquka amehlo e-15 kwizigulane ze-15 ze-OAG eziye zafumana i-microshunt ezizimeleyo kwaye zalandelwa kwiinyanga ze-3.Nangona kukho idatha kwi-intraocular yokunciphisa iziyobisi kunye noxinzelelo lwe-intraocular yokunciphisa iziyobisi, eyona njongo yethu yayikugxila kwiingxaki zasemva kokuhlinzwa.
Zonke izigulane zaziyiCaucasian, i-median (i-interquartile range, i-IqR) ubudala yayingu-76.0 (uluhlu lwe-71.8 ukuya kwi-84.3) iminyaka, i-6 (40.0%) yayingabasetyhini.Iimpawu eziphambili zedemografi kunye nekliniki zishwankathelwa kwiThebhile 2.
I-Median (IqR) i-IOP yehla ukusuka kwi-28.0 (27.0 ukuya kwi-32.5) mm Hg.Ubugcisa.ekuqaleni kwesifundo ukuya kwi-11.0 (10.0 ukuya kwi-12.0) mm Hg.Ubugcisa.emva kweenyanga ezi-3 (iHodges-Lehman umahluko ophakathi: -18.0 mmHg, i-95% yexesha lokuzithemba: -22.0 ukuya -14.0 mmHg, p = 0.0010) (Umfanekiso 2).Ngokufanayo, inani leziyobisi ze-ophthalmic antihypertensive lehle kakhulu ukusuka kwi-3.0 (2.2-3.0) iziyobisi kwisiseko ukuya kwi-0.0 (0.0-0.12) iziyobisi kwiinyanga ezi-3 (uHodges-Lehman uthetha umahluko: -2.5 iziyobisi) Iziyobisi, i-95% CI: -3.0 ukuya -2.0 Iziyobisi, p = 0.0007).Emva kweenyanga ezi-3, akukho namnye kwisigulana esathatha amayeza enkqubo ukuthoba i-IOP.
Umzobo 2 uthetha uxinzelelo lwe-intraocular ngexesha lokulandelela.Imivalo ethe nkqo imele uluhlu lwe interquartile. *p <0.005 xa kuthelekiswa nesiseko (uvavanyo lwe-Friedman kunye nohlalutyo lwe-post hoc yokuthelekisa i-pairwise yenziwe ngendlela ye-Conover). *p <0.005 xa kuthelekiswa nesiseko (uvavanyo lwe-Friedman kunye nohlalutyo lwe-post hoc yokuthelekisa i-pairwise yenziwe ngendlela ye-Conover). * p <0,005 по сравнению с исходным уровнем * p <0.005 xa kuthelekiswa nesiseko (uvavanyo lwe-Friedman kunye nohlalutyo lwe-post hoc yokuthelekisa i-pairwise yenziwa yi-Conover's method). *p < 0.005 与基线相比（弗里德曼检验和成对比较的事后分析是使用Conover 方法完成的）. *p <0.005 * p <0,005 по сравнению с исходным уровнем * p <0.005 xa kuthelekiswa nesiseko (uvavanyo lukaFriedman kunye nohlalutyo lwe-post hoc lokuthelekisa i-pairwise lwenziwa ngokusebenzisa indlela yeConover).
I-Visual acuity yehla kakhulu ngosuku lwe-1, iveki ye-1, kunye nenyanga ye-1 xa kuthelekiswa namaxabiso angaphambili, kodwa ibuyiselwe kwaye izinzile ukusuka kwinyanga ye-2 (umzobo 3).
Irayisi.3. Uphononongo lwe-median echanekileyo yokulungiswa komgama we-visual acuity (BCDVA) ngexesha lokulandelela.Imivalo ethe nkqo imele uluhlu lwe interquartile. *p <0.01 xa kuthelekiswa nesiseko (uvavanyo lwe-Friedman kunye nohlalutyo lwe-post hoc yokuthelekisa i-pairwise yenziwe ngendlela ye-Conover). *p <0.01 xa kuthelekiswa nesiseko (uvavanyo lwe-Friedman kunye nohlalutyo lwe-post hoc yokuthelekisa i-pairwise yenziwe ngendlela ye-Conover). *p < 0.01 по сравнению с исходным уровнем *p <0.01 xa kuthelekiswa nesiseko (uvavanyo lukaFriedman kunye nohlalutyo lwe-post hoc lokuthelekisa i-pairwise lwenziwa kusetyenziswa indlela yeConover). *p < 0.01 与基线相比（Friedman 检验和成对比较的事后分析是使用Conover 方法完成的）. *p <0.01 *p < 0,01 по сравнению с исходным уровнем *p <0.01 xa kuthelekiswa nesiseko (uvavanyo lukaFriedman kunye nohlalutyo lwe-post hoc yokuthelekisa i-pairwise yenziwa ngokusebenzisa indlela yeConover).
Ngokuphathelele ukhuseleko, amehlo amabini (13.3%) aphuhlise i-hyphema (malunga ne-1 mm) ngosuku lokuqala lwasemva kokuhlinzwa, oluye lwagqitywa ngokupheleleyo kwiveki.I-peripheral choroidal detachment yenzeke kumehlo amathathu (20.0%), eyasombulula ngempumelelo ngonyango lwezonyango kwinyanga enye.Akukho namnye kwizigulane ezifuna ukungenelela olongezelelweyo lotyando.
Idatha ekhoyo ngoku evavanya ukusebenza kunye nokhuseleko lweMicroShunt ibonisa iziphumo ezithembisayo, nangona zilinganiselwe.I-9-16 amava ogqirha kunye neziphumo zeklinikhi zibalulekile ekuphuculeni kunye nokwenza lula ubugcisa botyando.
Kweli nqaku, sijonge ukubonisa indlela ekhawulezayo, engaguqukiyo, kunye nelula yokufakelwa kwesi sixhobo.Idatha yeklinikhi yendlela yenzelwe ukujonga iingxaki zangaphambili ezinokudityaniswa nendlela, kwaye ingahlalutyi ukusebenza kwayo.
Isixhobo sineembambo ezimbini zecala, umsebenzi wethiyori kukuthintela ukuhamba kwecala kunye nokuhamba kweMicroShunt.I-6,8 Iindlela zemveli zibandakanya ukusetyenziswa kwe-blade ye-triangular ukudala i-pocket scleral engasemva kwe-limbus kunye ne-3 mm esondele kwi-limbus ukulungiselela ezi maphiko asecaleni.Nangona kunjalo, ubude bayo kunye nenyaniso yokuba i-pocket scleral iqala i-3 mm ukusuka kwi-limbus ibangela ukuba isixhobo siphume ngokuphawulekayo kwigumbi langaphambili.Ngenxa yoku, asifane sifake izixhobo ezinambambo ngaphantsi kwepokotho ye-scleral xa sisebenzisa ubuchule beklasikhi ukunqanda ukukhula kwesixhobo kwigumbi elingaphambili.
Ngeteknoloji yethu, i-stent ikhululekile ukuhamba kwaye igxothwe njengoko iimbambo zifikeleleka phantsi kweTenon capsule.Nangona kunjalo, kufuneka kugxininiswe ukuba akukho kususwa okwenzekayo kwisampulu yethu.
Ukusetyenziswa kweenaliti ukwenza i-scleral tunnels yezixhobo ezifakwe kwi-drainage edibeneyo ayikho into entsha.UAlbis-Donado et al.[17] inike ingxelo ngeziphumo zeklinikhi ezilungileyo kwizigulane ezafakelwa i-Ahmed valve implantation yeglaucoma ngokusebenzisa itonela eyenziwe ngenaliti ye-scleral ngaphandle kokusetyenziswa kwepatch yokugquma ityhubhu.
Kubuchule bethu, sasebenzisa i-25G kunye nobubanzi obungaphandle be-0.515 mm kunye nobude bomzila we-3 ukuya kwi-4 mm, eyaneleyo ukubamba ngokukhuselekileyo isixhobo.Ukunikezelwa kwe-MicroShunt ye-diameter yangaphandle ye-0.35mm, ukusebenzisa i-stylus encinci kunokubangela ukubamba okuzinzile kunye nokuhamba ngaphantsi kwecala.Iinaliti ze-26 (0.466), i-27G (0.413), okanye i-28G (0.362) ingasetyenziswa, kodwa asinamava ngeenaliti ezincinci ze-diameter.Uphononongo olongezelelweyo lwexesha eliphakathi nelide luyafuneka ukuvavanya olu khetho.
Enye ingxaki enokubakho kobu buchule kukukhukuliseka kwe-sclera.Nangona kunjalo, kufuneka kuqatshelwe ukuba ubuchule obufanayo obusebenzisa i-20G18 microvitreoretinal blade okanye inaliti enkulu ye-22-23G17 ichazwe kwi-Molteno implants ngaphandle kokufuduka okanye ukuguguleka kwe-18 kunye no-Ahmed kunye ne-tube encinci yokurhoxiswa (4/186).17
Ubuchwephesha benaliti buneenzuzo ezininzi kwiindlela zesintu zokufakelwa, njengenkqubo ekhawulezayo, inguqu ethambileyo phakathi kwe-conjunctiva kunye ne-cornea, kunye nesiganeko esisezantsi se-dellen kunye namadyunguza abuhlungu.17,18 Ukongeza, zombini izifundo zibonise ukuba ukungabikho kwe-corrosion kwakudityaniswa nokulingana okuqinileyo phakathi kombhobho kunye netonela, okubangela ukuba i-galling encinci kunye nokuguga.17.18
Ngokuphathelele ukhuseleko, izinga leengxaki ze-postoperative libonakala liphezulu kunokuba lichazwe kwamanye amanqaku, kodwa kufuneka kuqatshelwe ukuba siye sanyamekela ngokukhethekileyo ukubika iingxaki ze-prosaic kweli nqaku, kodwa akukho nanye kwezi ngxaki yayibaluleke kakhulu kwikliniki. .
Nangona iziganeko zeendlela zobuxoki azizange zichazwe kwizifundo zangaphambili ze-9-16, le ngxaki ye-intraoperative inokuthi yenzeke kwaye ibangele ukudala enye i-tunnel esecaleni, ukwandisa umngcipheko we-hyphema kwaye mhlawumbi ithathe indawo.indawo ethandeka kancinci.
Le ngxelo imfutshane inemida emininzi ekufuneka ikhankanywe.Kwezi, ezona zibalulekileyo kubungakanani besampulu esilinganiselweyo, ixesha elifutshane lokulandelela, kunye nokungabikho kweqela lolawulo.Nangona kunjalo, eli nqaku lichaza indlela ephucula kakhulu ukufakwa kwe-microshunt enezinga elifanayo le-intraoperative kunye neengxaki zokuqala emva kokuhlinzwa njengeendlela eziqhelekileyo.9-16
Ekugqibeleni, ukusetyenziswa kwenaliti ukudala indlela ye-intrascleral ibonise iziphumo ezithembisayo kweli qela elincinci lezigulane.Ukusetyenziswa kwayo kunokuba luncedo ngakumbi xa ubukho bezinye izixhobo bunciphisa indawo.Uphando olongezelelweyo luyafuneka ukufumanisa ukuzinza kwexesha elide lobu buchule kunye neenzuzo ezinokubakho zeenaliti ezincinci.
Ukubhalwa kwezonyango kunye neenkonzo zokuhlela zibonelelwa ngu-Antonio Martínez (MD), Ciencia y Deporte SL, kunye nenkxaso-mali engavumelekanga evela kwiYunivesithi yaseTurin.
Ababhali bangathanda ukubulela i-A Mazzoleni, i-L Guazzone, i-C Caiafa, i-E Suozzo, i-M Pallotta, kunye ne-M Grindi ngokubambisana kwabo ngexesha lokufunda.
UDkt Antonio M. Fea ungumcebisi weGlaukos, Ivantis, iSTAR, EyeD, kunye nomcebisi ohlawulwayo we-AbbVie, ngaphezu komsebenzi owenziweyo.UGqr Earl R. Craven ngoku ungumsebenzi wakwa-AbbVie kwaye unika ingxelo ngeendleko zobuqu ku-Santen ukongeza kumsebenzi owenziweyo.Ababhali baxela ezinye iingxabano zomdla kulo msebenzi.
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