I-FDA Igunyaza Uhlelo lwe-EVO Visian® ICL, Manje Iza E-Utah

Uma ukhathele ukubhekana ne-myopia kanye nokuthintana njalo noma ukuthintana nezibuko zamehlo, i-EVO Visian ICL™ (i-STAAR® Surgical Phakic ICL ye-Myopia ne-Astigmatism) ingase ibe yilokho obukade ukulindile, futhi ngemva kweminyaka engaphezu kwamashumi amabili ngaphandle kwe-Myopia. E-US, ekugcineni isiyatholakala e-Utah e-Hoopes Vision.
Ngomhla zingama-28 kuNdasa, 2022, i-STAAR Surgical Company, umkhiqizi ohamba phambili wamalensi afakelwayo, yamemezela esitatimendeni sabezindaba ukuthi i-US Food and Drug Administration (FDA) igunyaze i-EVO/EVO+ Visian® Implantable Collamer® Lens (EVO) njenge-Myopia ephephile. nge-astigmatism nangaphandle kanye nokwelashwa okusebenzayo e-US
"Angaphezu kwesigidi esingu-1 amalensi e-EVO afakwe odokotela ngaphandle kwase-US, kanti i-99.4% yeziguli ze-EVO ocwaningweni zithe zizohlinzwa futhi," kusho u-Caren Mason, umongameli kanye ne-CEO ye-STAAR Surgical.
"Ukuthengiswa kwamalensi e-EVO ngaphandle kwase-US kukhuphuke ngo-51% ngo-2021, okungaphezu kokuphindwe kabili kusukela ngo-2018, okubonisa ukukhetha okwandayo kweziguli kanye nozakwethu bodokotela abahlinzayo be-EVO njengenketho yokuqala yokulungiswa kwe-refractive nezixazululo ezinkulu."

Xhumana Nethuluzi Lokususa Ilensi

Xhumana Nethuluzi Lokususa Ilensi
Le nqubo esebenza kahle kakhulu yokulungisa umbono wosuku olufanayo ingaqedwa cishe emaminithini angu-20-30. Akukhona nje kuphela ukuthi inqubo iyashesha futhi ayinabuhlungu, i-EVO ICL inenzuzo yesikhathi sokululama ngokushesha, asikho isidingo samalensi okuxhumana nezibuko, futhi ithuthukisiwe. Ibanga kanye nokubona ebusuku cishe ubusuku bonke - kubantu abaningi abakhungathekiswe ama-contact lens noma izibuko, Iphupho liyafezeka.
I-Myopia, eyaziwa nangokuthi “ukubona eduze,” ingesinye sezimo zokubona ezivame kakhulu emhlabeni wonke, lapho umuntu ekwazi ukubona izinto eziseduze ngokucacile, kodwa izinto ezikude zibonakala zilufifi.NgokweNational Eye Institute (NEI), “Ucwaningo oluningi lubonisa ukuthi ukwanda kwe-myopia kuyanda e-United States nasemhlabeni wonke, futhi abacwaningi balindele ukuthi lesi simo siqhubeke emashumini eminyaka ezayo.”
I-Myopia yenzeka lapho amehlo omuntu ekhula amade kakhulu ukusuka phambili kuya emuva, okubangela ukukhanya kufulathele noma “kugobe” ngokungalungile.Cishe amaphesenti angu-41.6 abantu baseMelika ababoni eduze, “enyuka isuka kumaphesenti angu-25 ngo-1971,” kusho umbiko we-NEI.
I-STAAR Surgical ilinganisela ukuthi abantu abadala base-US abayizigidi ezingu-100 abaphakathi kweminyaka engu-21 no-45 bangase babe abantu abangase bakhethe i-EVO, ilensi ebekezelelwa kahle elungisa ukubona kude komuntu, ebavumela ukuthi babone izinto ezikude kakhulu.
Amalensi e-EVO Visian ayaziwa nangokuthi “Amalensi Angafakwa I-Collamer®”. Amalensi enziwe ngezinto ze-STAAR Surgical’s proprietary Collamer. Aqukethe inani elincane le-collagen ehlanzekile futhi enye yonke yenziwe ngento efanayo etholakala kumalensi okuxhumana athambile.I-Collamer ithambile , ezinzile, eziguquguqukayo kanye ne-biocompatible.I-Collamer inomlando wokusetshenziswa ngempumelelo kwe-intraocular emhlabeni jikelele futhi ifakazele ukuthi iyinto esebenza kahle ye-lens ye-ophthalmic.
Ngaphambi kokuhlinzwa kwe-EVO Visian ICL, udokotela wakho uzokwenza uchungechunge lokuhlola ukukala izici eziyingqayizivele zeso lakho.Masinyane ngaphambi kokuhlinzwa, udokotela wakho uzosebenzisa amaconsi iso ukuze avule abafundi bakho futhi avale amehlo akho ndikindiki.Okulandelayo, ilensi ye-EVO ICL izoba agoqwe afakwe embotsheni encane ye-cornea.

Xhumana Nethuluzi Lokususa Ilensi

Xhumana Nethuluzi Lokususa Ilensi
Ngemva kokufaka i-lens, udokotela uzokwenza noma yiziphi izinguquko ezidingekayo ukuze aqinisekise ukuma okulungile kwelensi.I-lens izobekwa ngokuqinile ngemuva kwe-iris (ingxenye enemibala yeso) naphambi kwelensi yemvelo.Uma ilensi isikhona. ifakiwe, wena nabanye anikwazi ukuyibona, futhi ilensi ethambile, eguquguqukayo ilingana kahle neso lakho lemvelo.
Ngaphezu kweminyaka engama-20, amalensi e-STAAR afakelwayo e-Collamer abesiza iziguli ukuthi zikwazi ukubona kangcono, zizikhulula ezingilazini nasemalensi okuxhumana, futhi ekugcineni, i-EVO ICL yathola imvume ye-FDA yeziguli zase-US.
"Siyajabula ukunikeza i-EVO kodokotela abahlinzayo base-US kanye neziguli ezifuna inketho efakazelwe yezibuko zamehlo eziphezulu, amalensi okuxhumana, noma ukulungiswa kombono we-laser," kusho uScott D. Barnes, MD, Isikhulu Esiyinhloko Sezokwelapha se-STAAR Surgical.“Isimemezelo sanamuhla sibaluleke kakhulu, Ngenxa yokuthi ukwanda kwe-myopia kukhula ngokushesha, izinyathelo zokuphepha ze-COVID ziletha izinselele ezengeziwe kulabo abagqoka izibuko kanye/noma amalensi okuxhumana nabo.
“I-EVO yengeza ithuluzi elibalulekile kodokotela bamehlo abafuna ukusiza ukuthuthukisa izinga lempilo yesiguli.Ngokungafani ne-LASIK, amalensi e-EVO engezwa esweni lesiguli ngenqubo yokuhlinzwa esheshayo, ngaphandle kwesidingo sokukhipha izicubu zekhone.Ngaphezu kwalokho, uma kufunwa, odokotela bangasuswa ama-lens e-EVO.Imiphumela yocwaningo lwethu lwakamuva lomtholampilo e-US ihambisana namalensi e-EVO angaphezu kwesigidi afakwe emhlabeni wonke.”
I-EVO iyindlela yokulungiswa kombono egunyazwe yi-FDA yeziguli ezine-myopic noma ezingenazo i-astigmatism ezifuna ukuqeda isidingo sezibuko noma amalensi okuxhumana. Nakuba i-EVO iyisixazululo sesikhathi eside sokukhulula iziguli ekuphazamisekeni kwansuku zonke kokuxhumana nokugqoka izibuko, it kungenzeka ukuthi i-EVO ayibafanele labo abaye babhekana ne-LASIK, njengoba le nqubo ayizange isungulwe njengenqubo ephephile ezigulini ezinomlando wesifo samehlo .
Ingabe usukulungele ukuphila impilo egcwele? Ukuze uthole ukuthi uhlelo lwe-EVO ICL lukulungele yini, sicela uthinte i-Hoopes Vision ukuze uhlele ukubonisana kwakho ne-VIP. Kwa-Hoopes Vision, iziguli zijabulela irekhodi elihle kakhulu lokuphepha nemiphumela eqinisekisiwe, kuyilapho zazisa ukuthi zikwenza kanjani lokho. benze konke abangakwenza ukuze ukulungisa kahle kombono kufinyeleleke futhi kufinyeleleke ezigulini ezinezabelomali ezahlukene.


Isikhathi sokuthumela: May-21-2022