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Antonio M. Fea, 1 Andrea Gilardi, 1 Davide Bovone, 1 Michele Reibaldi, 1 Alessandro Rossi, 1 Earl R. Craven21 Diploma na Jami'ar Ophthalmological Scientific na Turin, Turin, Italiya;2 Johns Hopkins University, Baltimore, Maryland, Amurka Cibiyar Glaucoma Elmer Eye Cibiyar Glaucoma Mawallafi Mawallafi: Antonio M. Fea, +39 3495601674, imel [email protected] Abstract: PRESERFLO™ MicroShunt sabuwar na'ura ce don aikin tiyata na glaucoma kadan (MIGS) ) dasa ab externo, abin jin daɗi na ruwa yana zubar da shi cikin sararin samaniya.An haɓaka shi azaman magani mafi aminci kuma mara ƙarfi ga marasa lafiya tare da glaucoma na farko mara sarrafa magani (POAG).Hanyar gargajiya ta MicroShunt dasawa ta ƙunshi matakai masu mahimmanci daban-daban, gami da ƙirƙirar ƙaramin aljihun scleral tare da ruwan wukake na 1mm, saka allurar 25G (25G) ta cikin aljihun scleral a cikin ɗaki na gaba (AC), sannan kuma siriri mai bango 23-ma'auni ( 23G) Cannula yana zubar da stent.Duk da haka, shigar da allura a cikin aljihun scleral yana haifar da tashar da ba daidai ba, yana da wuya a zaren na'urar.Manufar wannan labarin shine don ba da shawarar hanya mai sauƙi na dasa.Hanyarmu tana ba da shawarar yin rami na scleral ta amfani da allurar 25G kai tsaye da amfani da wannan allurar 25G a cikin limbus don ɗan ɗan tura sclera cikin AC.An haɗa MicroShunt akan cannula na 23G wanda aka makala zuwa sirinji 1ml.Sannan ana iya wanke na'urar da sirinji.Don haka, ana iya tabbatar da fitowar waje nan da nan ta hanyar lura da ɗigon ruwa da ke zubowa daga buɗewar stent.Wannan sabon tsarin zai iya samun fa'idodi daban-daban kamar mafi kyawun sarrafa wurin shiga, guje wa ɓangarorin ƙarya, raguwa ko kawar da haɗarin fitowar ɓarna a gefe, haɓaka hanyar layi ɗaya zuwa jirgin saman iris, da saurin gudu.Kalmomi masu mahimmanci: MIGS, glaucoma mai buɗewa, Preserflo, MicroShunt, tiyata glaucoma, tacewa subconjunctival.
A cikin ƴan shekarun da suka gabata, ɗan ƙaranci ko aikin tiyata kaɗan (MIGS) ya bayyana a fagen aikin tiyatar glaucoma.1-5 Wadannan na'urorin MIGS an ƙera su ne don kula da marasa lafiya marasa kulawa tare da glaucoma na farko na budewa (POAG) don inganta aminci yayin kiyaye tasirin rage karfin intraocular (IOP).1-5 MIGS na'urorin za a iya raba zuwa: trabecular, suprachoroidal, da subconjunctival.1,3 Subconjunctival outflow yana kwaikwayon tsarin trabeculectomy.Idan aka kwatanta da trabeculectomy, yana ba da ƙananan matsa lamba na intraocular bayan aiki, yana ba da daidaitattun hanyoyin da mafi aminci.1-5 Duk na'urorin haɗin gwiwa sun dogara ne akan dasa tubule.An kiyasta ma'aunin lumen na waɗannan na'urori ta amfani da ma'aunin laminar Hagen-Poiseuille.1 Gabaɗaya, an zaɓi lumen don hana hauhawar jini na yau da kullun kuma yana da girma sosai don guje wa ɓoyewa.
Kodayake akwai wasu muhawara game da la'akari da MicroShunt a matsayin MIGS, don dalilan wannan takarda, kalmar MIGS za a yi amfani da ita.PreserfloTM MicroShunt implant an ƙaddamar da kwanan nan.6 Shunt ɗin ya ƙunshi shingen polystyrene, toshe isobutylene, styrene polymer wanda aka yi amfani da shi a baya azaman stent na jijiyoyin jini saboda yana haifar da ƙarancin kumburi da ɓoyewa.7,8 Na'urar tana da tsayin mm 8.5 kuma tana da lumen na 70 µm don sarrafa kwarara da kiyaye IOP sama da 5 mmHg.(tare da matsakaicin samar da ruwa).8 Tsawon na'urar yana ba da damar fitowar ruwa mafi girma, don haka ana ba da shawarar inci gaba mai faɗi.
Gabaɗaya, ƙaƙƙarfan ƙaƙƙarfan ƙaƙƙarfan wuri shine wurin da aka fi so don dasawa saboda yana guje wa samun dama ga tsokar dubura mafi girma.Matsakaicin Mitomycin-C (MMC) da lokutan fallasa sun bambanta dangane da abubuwan haɗari ko ƙwarewar likitan fiɗa.9-16
Wannan taƙaitaccen bayanin an yi niyya ne don fayyace ƙarin gyare-gyare ga hanya don sauri da sauƙi dasa shuki MicroShunt.
Kwamitin da'a na Jami'ar Turin ya amince da bitar bayanan likita.Saboda wannan bita ne na bayanan likitanci, kwamitin da'a ya yi watsi da buƙatun don samun rubutaccen izini don shiga cikin binciken.Koyaya, duk mahalarta sun ba da izini a rubuce kafin a yi musu tiyata.
Don tabbatar da keɓantawar majiyyaci, bayanansu ba a ɓoye sunansu ta hanyar amfani da na musamman masu ganowa.Tsarin binciken ya bi ka'idodin Sanarwa na Helsinki da Sharuɗɗa don Kyakkyawar Ayyukan Clinical/Kwamitin Gudanar da Ƙasashen Duniya.
Binciken da aka yi a yanzu ya haɗa da marasa lafiya na POAG a jere ≥18 shekaru da kuma marasa lafiya da aka yi wa magani tare da IOP ≥23 mmHg wanda aka yi amfani da shi na MicroShunt mai zaman kansa.
Ana ba da PRESERFLOTM MicroShunt (Santen ex Innfocus, Miami, FL, Amurka) a cikin kayan marufi maras kyau wanda ke ɗauke da alamar scleral 3 mm, ruwa mai triangular 1 mm, 3 Garkuwan LASIKTM (EYETEC, Antwerp, Belgium), alama da girman 25 allura (25G).
Kafin amfani da MicroShunt, masana'anta sun ba da shawarar sake cikawa tare da cannula na 23G, wanda ba a haɗa shi cikin kit ɗin ba.
Duk da yake yana da ƙari cewa likitocin glaucoma sun saba da tsarin dasa shuki na gargajiya, wasu matakai na iya zama ƙalubale.Musamman, lokacin da allurar 25G ta zame, titinsa na iya ƙirƙirar tashar da ba daidai ba / kuskure a cikin wani jirgin sama daban ko shigar da ɗakin gaba ba tare da isa saman ramin scleral ba.Yana da matukar wahala a sarrafa hanyar allurar 25G saboda sarari a cikin rami na scleral yana da kama-da-wane, ko kuma aƙalla sosai (duba hoto 1).
Hoto 1. Bayyani na manyan matakai na sabuwar fasahar tiyata.(A) An tsara allurar don shiga cikin sclera 3 mm daga gefen.(B) Da zarar allura ta kai ga gaɓoɓin, sai a tura ta ƙasa.(C) Allura ta shiga ɗakin gaba.(D) Bayan ƙirƙirar rami tare da ruwa mai siffar triangular, hanyar allurar da ake amfani da ita don shiga ɗakin gaba bazai iya bin ramin ba, ƙirƙirar hanyar ƙarya.
A wasu lokuta, wannan matsala na iya sa shigar da microshunt a cikin ɗakin baya (AC) da wuya saboda an toshe tip a cikin rami.Bugu da kari, wannan magudi na iya zama da wahala a idanu tare da rashin lafiyar jiki.
Hakanan, idan har yanzu ƙoƙarin na biyu ya gaza, ana iya tilasta wa likitan dasa na'urar cikin tsari mafi fa'ida.Wannan rukunin yanar gizon ya fi dacewa da tabo na gaba saboda kasancewar mafi girman ciki.
Don guje wa wannan matsalar, zaɓi ɗaya shine a yi wa AK allura da titin microknife da ake amfani da shi don ƙirƙirar aljihun scalal.Duk da yake wannan hanyar tana adana lokaci kuma tana hana ƙirƙirar sakin layi na kuskure, yana iya zama da wahala a kimanta tsawon AC mai shigowa.Bugu da ƙari, siffar triangular na ruwa yana bayyana hanya mafi girma, wanda ke haifar da motsi na gefe a farkon lokacin aiki.Bisa ga dokar Poiseuille, magudanar ruwa ta gefe kuma tana lalata yunƙurin haifar da fitowar ruwa daga AC, wanda zai iya ba da gudummawa ga haɓakar hauhawar jini.
Ƙwararren aikin mu yana ba da gyare-gyare guda biyu akan hanyoyin tiyata na gargajiya.Na farko shine a yi amfani da allurar 25G kai tsaye azaman rami.A matsayin ci gaba na biyu, dabararmu ta ba da shawarar haɗa cannula na 23G, wanda galibi ana amfani da shi don burin mai na silicone, zuwa ƙarshen MicroShunt.Don haka, likitan tiyata zai iya zubar da na'urar kai tsaye yayin shigar da zaren.
Yin amfani da allurar 25G don ƙirƙirar rami yana sauƙaƙa aikin tiyata yayin da yake kawar da buƙatar aljihun scleral kuma yana rage girman yankin da ke cikin hanyar.Bugu da ƙari, wannan haɓakawa yana taimakawa wajen rage yiwuwar lalacewa na dogon lokaci ga ƙwayoyin endothelial ta hanyar matsawa sclera yayin da yake gabatowa ga limbus, don haka shigar da iris a cikin wani jirgin sama mai kama da juna (duba Hoto 1 da ƙarin bidiyo).
Haɓaka na biyu da sabuwar fasahar ke bayarwa shine amfani da 23G cannula, mai kama da cannula da aka saba amfani da shi don buƙatun mai na silicone.Wannan cannula na 23G yana daidaita MicroShunt daidai kuma yana sauƙaƙawa.Bugu da kari, ruwan da aka yi masa allura a cikin AC shima yana kara matsa lamba, yana barin barkwanci mai ruwa ya rika gudana ta karshen na'urar (duba Hoto na 1 da karin bidiyo).
Kwarewar mu na asibiti sun haɗa da idanu 15 daga marasa lafiya na 15 OAG waɗanda suka sami microshunt mai zaman kanta kuma an bi su har tsawon watanni 3.Ko da yake akwai bayanai kan magungunan rage matsi na intraocular da magungunan rage matsi, babban burinmu shine mu mai da hankali kan rikice-rikicen da suka biyo baya.
Duk marasa lafiya sun kasance Caucasian, matsakaici (kewayon tsaka-tsaki, IqR) shekaru 76.0 (kewayon 71.8 zuwa 84.3) shekaru, 6 (40.0%) mata ne.An taƙaita mahimman ƙididdigar alƙaluma da halayen asibiti a cikin Tebur 2.
Matsakaicin (IqR) IOP ya ragu daga 28.0 (27.0 zuwa 32.5) mm Hg.Art.a farkon binciken zuwa 11.0 (10.0 zuwa 12.0) mm Hg.Art.bayan watanni 3 (Bambanci tsakanin Hodges-Lehman: -18.0 mmHg, 95% tazarar amincewa: -22.0 zuwa -14.0 mmHg, p=0.0010) (Fig. 2).Hakazalika, adadin magungunan antihypertensive ophthalmic ya ragu sosai daga 3.0 (2.2-3.0) kwayoyi a asali zuwa 0.0 (0.0-0.12) kwayoyi a watanni 3 (Hodges-Lehman yana nufin bambanci: -2.5 kwayoyi) Drug, 95% CI: -3.0 zuwa -2.0 Drug, p = 0.0007).Bayan watanni 3, babu wani daga cikin marasa lafiya da ya dauki magungunan tsarin don rage IOP.
Hoto 2 Ma'anar matsa lamba na intraocular yayin bibiya.Sandunan tsaye suna wakiltar jeri na tsaka-tsaki. *p <0.005 kamar yadda aka kwatanta da asali (gwajin Friedman da bincike na hoc don kwatance biyu an yi tare da hanyar Conover). *p <0.005 kamar yadda aka kwatanta da asali (gwajin Friedman da bincike na hoc don kwatance biyu an yi tare da hanyar Conover). * p <0,005 по сравнению с исходным уровнем Коновера). * p <0.005 idan aka kwatanta da asali (Gwajin Friedman da bincike bayan hoc don kwatancen hanya biyu an yi ta hanyar Conover). *p < 0.005 *p <0.005 * p <0,005 по сравнению с исходным уровнем ванием метода Коновера). * p <0.005 idan aka kwatanta da asali (Gwajin Friedman da bincike na hoc don kwatancen nau'i-nau'i an yi su ta hanyar hanyar Conover).
Ƙwararren gani ya ragu sosai a ranar 1, mako 1, da watan 1 idan aka kwatanta da dabi'un da aka riga aka yi, amma an dawo da su kuma sun daidaita daga watan 2 (Fig. 3).
Shinkafa3. Yin bita na tsaka-tsakin maximally gyara nesa na gani (BCDVA) yayin biyowa.Sandunan tsaye suna wakiltar jeri na tsaka-tsaki. *p <0.01 kamar yadda aka kwatanta da tushe (gwajin Friedman da bincike na hoc don kwatance biyu an yi tare da hanyar Conover). *p <0.01 kamar yadda aka kwatanta da tushe (gwajin Friedman da bincike na hoc don kwatance biyu an yi tare da hanyar Conover). *p <0,01 по сравнению с исходным уровнем Коновера). *p <0.01 idan aka kwatanta da asali (Gwajin Friedman da bincike na bayan hoc don kwatance biyu an yi su ta hanyar hanyar Conover). *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 ванием метода Коновера). *p <0.01 idan aka kwatanta da tushe (Gwajin Friedman da bincike na hoc don kwatance biyu an yi su ta hanyar hanyar Conover).
Game da aminci, idanu guda biyu (13.3%) sun haifar da hyphema (kimanin 1 mm) a ranar farko bayan aiki, wanda ya warware gaba ɗaya cikin mako guda.Ƙwararren choroidal na gefe ya faru a cikin idanu uku (20.0%), wanda ya yi nasara tare da maganin likita a cikin wata daya.Babu wani daga cikin majiyyatan da ya buƙaci ƙarin aikin tiyata.
Bayanan da ake samu a halin yanzu suna kimanta inganci da amincin MicroShunt suna nuna sakamako masu ban sha'awa, kodayake iyakance.9-16 Kwarewar likitan tiyata da sakamakon asibiti suna da mahimmanci ga haɓakawa da sauƙaƙe dabarun tiyata.
A cikin wannan labarin, muna nufin nuna fasaha mai sauri, daidaito da sauƙi don dasa wannan na'urar.An tsara bayanan asibiti don hanyar don nemo matsalolin farko waɗanda za a iya danganta su da hanyar, kuma ba don nazarin tasirin sa ba.
Na'urar tana da haƙarƙari biyu na gefe, aikin ƙa'idar wanda shine don hana yiwuwar kwararar gefe da motsi na MicroShunt.6,8 Hanyoyi na al'ada sun haɗa da yin amfani da ruwa mai siffar triangular don ƙirƙirar aljihun scleral marar zurfi a baya zuwa ga limbus da 3 mm kusa da limbus don ɗaukar waɗannan fins na gefe.Duk da haka, tsayinsa da gaskiyar cewa aljihun scleral yana farawa 3 mm daga limbus yana haifar da na'urar da ke fitowa sosai a cikin ɗakin da ke gaba.Saboda haka, ba kasafai muke dasa na'urorin ribbed a ƙasan aljihun scleral lokacin amfani da dabarar gargajiya don hana girmar na'urar a ɗakin gaba.
Tare da fasahar mu, stent yana da 'yanci don motsawa da ƙaura kamar yadda haƙarƙari ke samun dama a ƙarƙashin capsule na Tenon.Duk da haka, ya kamata a jaddada cewa babu raguwa a cikin samfurin mu.
Amfani da allura don ƙirƙirar ramukan scleral don na'urorin magudanar ruwa da aka dasa ba sabon abu bane.Albis-Donado et al.[17] ya ba da rahoton sakamako mai kyau na asibiti a cikin marasa lafiya da ke jurewa Ahmed bawul don glaucoma ta hanyar ramin scleral da aka yi da allura ba tare da amfani da facin bututu ba.
A cikin fasahar mu, mun yi amfani da 25G tare da diamita na waje na 0.515 mm da tsayin waƙa na 3 zuwa 4 mm, wanda ya isa ya riƙe na'urar a wuri.Idan aka yi la'akari da diamita na waje na MicroShunt na 0.35mm, yin amfani da ƙaramin salo na iya haifar da ingantaccen riko da ƙarancin kwarara ta gefe.Ana iya amfani da allura 26 (0.466), 27G (0.413), ko ma 28G (0.362), amma ba mu da gogewa da ƙananan alluran diamita.Ana buƙatar ƙarin nazarin matsakaici da na dogon lokaci don kimanta waɗannan zaɓuɓɓukan.
Wata matsala mai yuwuwa tare da wannan fasaha shine zaizayar sclerosis.Duk da haka, ya kamata a lura da cewa irin wannan fasaha ta amfani da 20G18 microvitreoretinal blade ko mafi girma 22-23G17 allura an bayyana shi don Molteno implants ba tare da ƙaura ko yashwa18 da Ahmed tare da ƙananan tube retraction (4/186).17
Dabarar allura tana da fa'idodi da yawa akan hanyoyin dasawa na gargajiya, kamar hanya mai sauri, rarrabuwar kawuna tsakanin conjunctiva da cornea, da raguwar kamuwa da blisters da raɗaɗi.17,18 Bugu da ƙari, duka binciken sun nuna cewa rashin lalata yana da alaƙa da matsananciyar matsa lamba tsakanin bututu da rami, wanda ya haifar da raguwa da lalacewa.17.18
Dangane da aminci, yawan rikice-rikicen bayan tiyata ya bayyana ya ɗan fi girma fiye da yadda aka ruwaito a wasu labaran, amma ya kamata a lura cewa mun ba da kulawa ta musamman don ba da rahoton ko da rikice-rikice na prosaic a cikin wannan labarin, amma babu ɗayan waɗannan matsalolin da ke da mahimmancin asibiti. .
Ko da yake ba a ba da rahoton abubuwan da suka faru na ramukan karya ba a cikin binciken da suka gabata9-16, wannan rikice-rikice na ciki na iya faruwa kuma ya haifar da ƙirƙirar wani rami na gefe, yana ƙara haɗarin hyphema da yiwuwar ɗaukar sarari.kasa m matsayi.
Wannan taƙaitaccen rahoto yana da iyakoki da yawa waɗanda ke buƙatar ambaton su.Daga cikin waɗannan, mafi mahimmanci shine ƙayyadadden girman samfurin, ɗan gajeren lokaci mai biyo baya, da rashin ƙungiyar kulawa.Duk da haka, wannan labarin ya bayyana hanyar da ta inganta mahimmancin shigar da microshunt tare da ƙimar intraoperative da farkon rikice-rikice na farko kamar yadda hanyoyin al'ada.9-16
A ƙarshe, yin amfani da allura don ƙirƙirar hanyar intrascleral ya nuna sakamako mai ban sha'awa a cikin wannan ƙananan marasa lafiya.Amfani da shi na iya zama da amfani musamman lokacin da kasancewar sauran kayan aiki ke iyakance sarari.Ana buƙatar ƙarin bincike don sanin dorewar kwanciyar hankali na wannan fasaha da yuwuwar fa'idodin ƙananan allura.
Rubutun likitanci da sabis na edita ana bayar da su ta Antonio Martínez (MD), Ciencia y Deporte SL, tare da tallafin da ba a iyakance ba daga Jami'ar Turin.
Har ila yau, marubutan za su so su gode wa A Mazzoleni, L Guazzone, C Caiafa, E Suozzo, M Pallotta, da M Grindi don haɗin gwiwar da suka yi a lokacin binciken.
Dr. Antonio M. Fea mai ba da shawara ne ga Glaukos, Ivantis, iSTAR, EyeD, da kuma mai ba da shawara ga AbbVie, ban da aikin da aka gabatar.Dr. Earl R. Craven a halin yanzu ma'aikaci ne na AbbVie kuma yana ba da rahoton kuɗaɗen sirri ga Santen ban da aikin da aka gabatar.Marubutan ba su bayar da rahoton wasu rikice-rikice na sha'awa a cikin wannan aikin ba.
1. Ansari E. Sabbin fahimta game da dasa shuki don aikin tiyata na glaucoma kaɗan (MIGS).hawaye.2017;6 (2):233–241.doi: 10.1007/s40123-017-0098-2
2. Bar-David L., Blumenthal EZ Juyin aikin tiyatar glaucoma a cikin shekaru 25 da suka gabata.Rambam Maimonides Med J. 2018; 9 (3): e0024.DOI: 10.5041/RMJ.10345.
3. Mathew DJ, YM ya saya.Ƙananan glaucoma tiyata: ƙima mai mahimmanci na wallafe-wallafe.Annu Rev Vis Sci.2020; 6:47-89.doi:10.1146/annurev-vision-121219-081737
4. Vinod K., Gerd SJ Amintaccen aikin tiyata na glaucoma kaɗan.Kurr Opin Ophthalmology.2021;32 (2): 160-168.doi: 10.1097/ICU.000000000000731
5. Pereira ICF, van de Wijdeven R, Wyss HM et al.Tsarin glaucoma na gargajiya da sabbin na'urorin MIGS: cikakken bita na zaɓuɓɓukan yanzu da kwatance na gaba.Ido.2021;35 (12):3202–3221.doi: 10.1038/s41433-021-01595-x
6. Lee RMH, Bouremel Y, Eames I, Brocchini S, Khaw PT.Fassarar kayan aiki don ƙananan ƙwayar cutar glaucoma.Kimiyyar Fassarar Clinical.2020; 13 (1): 14-25.doi: 10.1111/cts.12660
7. Pinchuk L, Wilson J, Barry JJ et al.Amfani da likita na poly (styrene-block-isobutylene-block-styrene) ("SIBS").biomaterials.2008;29 (4):448–460.doi:10.1016/j.biomaterials.2007.09.041
8. Beckers Yu.M., Pinchuk L. Minimally invasive glaucoma tiyata ta amfani da sabon Ab-exerno subconjunctival shunt - matsayi da wallafe-wallafen bita.Ɗabi'ar Idon gani na Turai 2019;13(1):27–30.doi: 10.17925/EOR.2019.13.1.27