I-FDA ivuma iNkqubo ye-EVO Visian® ICL, ngoku Iza e-Utah

Ukuba udiniwe kukujongana ne-myopia kunye nokunxibelelana rhoqo okanye ukudibana kweglasi yamehlo, i-EVO Visian ICL™ (i-STAAR® Surgical Phakic ICL ye-Myopia kunye ne-Astigmatism) inokuba yile nto ubuyilindile, kwaye emva kweminyaka engaphezu kwamashumi amabini US, ekugqibeleni iyafumaneka eUtah eHoopes Vision.
Ngomhla wama-28 kuMatshi ka-2022, i-STAAR Surgical Company, umvelisi ohamba phambili weelensi ezifakelwayo, yabhengeza kwingxelo yeendaba ukuba i-US Food and Drug Administration (FDA) yamkele i-EVO/EVO+ Visian® Implantable Collamer® Lens (EVO) njengeMyopia ekhuselekileyo. kunye nangaphandle kwe-astigmatism kunye nonyango olusebenzayo e-US
"Ngaphezu kwe-1 yezigidi ze-EVO lens zifakwe ngoogqirha ngaphandle kwe-US, kwaye i-99.4% yezigulane ze-EVO kwi-survey bathi baya kuphinda batyandwe kwakhona," kusho u-Caren Mason, umongameli kunye ne-CEO ye-STAAR Surgical.
"Ukuthengiswa kweelensi ze-EVO ngaphandle kwe-US kunyuke ngeepesenti ezingama-51 ngo-2021, ngaphezulu kokuphindwe kabini ukusukela ngo-2018, kubonisa ukhetho olwandayo lwezigulana kunye namaqabane ethu otyando lwe-EVO njengeyona ndlela iphambili yolungiso kunye nezisombululo ezinkulu."

Qhagamshelana nesixhobo sokuSuswa kweLens

Qhagamshelana nesixhobo sokuSuswa kweLens
Le nkqubo yokulungiswa kombono yosuku olunye esebenzayo kakhulu ingagqitywa malunga ne-20-30 imizuzu.Ayisiyo kuphela inkqubo ekhawulezayo kwaye ayinabuhlungu, i-EVO ICL inenzuzo yexesha lokubuyisela ngokukhawuleza, akukho mfuneko yeelensi zoqhagamshelwano kunye neeglasi, kwaye ziphuculwe. Umgama kunye nombono wasebusuku phantse ngobusuku - kubantu abaninzi abadangele iilensi zoqhagamshelwano okanye iiglasi, Iphupha lizaliseka.
I-Myopia, ekwabizwa ngokuba “kukubona kufutshane,” yenye yezona meko zixhaphakileyo zokubona kwihlabathi liphela, apho umntu angabona izinto ezikufutshane ngokucacileyo, kodwa izinto ezikude zibonakala ziluzizi. ukuxhaphaka kwe-myopia kuyanda eUnited States nakwihlabathi jikelele, yaye abaphandi balindele ukuba le meko iqhubeke kumashumi eminyaka ezayo.”
I-Myopia yenzeka xa amehlo omntu ekhula kakhulu ukusuka ngaphambili ukuya ngasemva, ebangela ukukhanya kukhanye okanye "kugobe" ngendlela engafanelekanga. Malunga nama-41.6 ekhulwini abantu baseMerika babona kufutshane, "ukusuka kuma-25 ekhulwini ngo-1971," yatsho ingxelo ye-NEI.
I-STAAR Utyando luqikelela ukuba i-100 yezigidi zabantu abadala base-US abaphakathi kweminyaka eyi-21 kunye ne-45 banokuba ngabaviwa abanokuthi babe ngabaviwa be-EVO, i-lens enyamezeleke kakuhle elungisa umbono womgama womntu, evumela ukuba babone izinto ezikude kakhulu.
Iilensi ze-EVO Visian zikwabizwa ngokuba zii-“Implantable Collamer® Lenses”.IiLens zenziwe ngezinto ze-STAAR Surgical's proprietary Collamer.Iqulethe i-collagen encinci ecocekileyo kwaye enye iyenziwa ngezinto ezifanayo ezifumaneka kwiilensi zoqhagamshelwano ezithambileyo.I-Collamer ithambile , ezinzile, eziguquguqukayo kunye ne-biocompatible.I-Collamer inembali yokusetyenziswa ngempumelelo kwi-intraocular kwihlabathi jikelele kwaye ibonakalise ukuba yinto ekhululekile kunye nesebenzayo yelensi ye-ophthalmic.
Ngaphambi kokuhlinzwa kwe-EVO Visian ICL, ugqirha wakho uya kwenza uluhlu lweemvavanyo zokulinganisa iimpawu ezikhethekileyo zeso lakho.Kwangoko ngaphambi kokuhlinzwa, ugqirha wakho uya kusebenzisa amaconsi esweni ukuze ahlaziye abafundi bakho kwaye adibanise amehlo akho.Okulandelayo, i-lens ye-EVO ICL iya kuba isongwe yaza yafakwa kwindawo encinci kwilungu le-cornea.

Qhagamshelana nesixhobo sokuSuswa kweLens

Qhagamshelana nesixhobo sokuSuswa kweLens
Emva kokufaka i-lens, ugqirha uya kwenza naluphi na uhlengahlengiso oluyimfuneko ukuze kuqinisekiswe indawo echanekileyo ye-lens.I-lens iya kufakwa ngokuqinileyo emva kwe-iris (inxalenye enemibala yeso) kwaye phambi kwe-lens yendalo. efakiweyo, wena nabanye aniyiboni, kwaye ilensi ethambileyo, ethambileyo ilingana kakuhle neliso lakho lenyama.
Ngaphezulu kweminyaka engama-20, iilensi ze-STAAR ezifakelwayo zeCollamer bezinceda izigulana ukuba zifezekise umbono ongcono, zizikhulula kwiiglasi kunye neelensi zoqhagamshelwano, kwaye ekugqibeleni, i-EVO ICL ifumene imvume ye-FDA kwizigulana zase-US.
"Siyavuya ukubonelela nge-EVO kwiingcali zogqirha zase-US kunye nezigulane ezifuna inketho eqinisekisiweyo yezibuko zamehlo eziphezulu, iilensi zoqhagamshelwano, okanye ukulungiswa kombono we-laser," kusho uScott D. Barnes, MD, iGosa eliyiNtloko lezoNyango ze-STAAR Surgical.“Isibhengezo sanamhlanje sibaluleke kakhulu, Ngenxa yokuba ukuxhaphaka kwe-myopia kusanda ngokukhawuleza, izilumkiso ze-COVID zibeka imingeni eyongezelelweyo kwabo banxiba iiglasi kunye/okanye iilensi zokunxibelelana.
“I-EVO yongeza isixhobo esibalulekileyo kwiingcali zamehlo ezijonge ukunceda ukuphucula umgangatho wobomi besigulana.Ngokungafaniyo ne-LASIK, iilensi ze-EVO zongezwa kwiliso lesigulane ngenkqubo yotyando olukhawulezayo, ngaphandle kwesidingo sokususa izicubu ze-cornea.Ukongeza, ukuba unqwenela, oogqirha banokususwa iilensi ze-EVO.Iziphumo zolingo lwethu lwamva nje lwezonyango e-US ziyangqinelana neelensi ze-EVO ezingaphezu kwesigidi ezifakelwe kwihlabathi liphela.”
I-EVO yindlela yokulungiswa kombono evunyiweyo yi-FDA kwizigulane ze-myopic okanye ngaphandle kwe-astigmatism efuna ukuphelisa imfuno yeeglasi okanye iilensi zoqhagamshelwano.Ngelixa i-EVO iyisisombululo sexesha elide ukukhulula izigulane kwi-incontainability yemihla ngemihla yoqhagamshelwano kunye nokugqoka iiglasi, it. kusenokwenzeka ukuba i-EVO ayifanelekanga kwabo baye bafumana i-LASIK, njengoko inkqubo ayizange isungulwe njengenkqubo ekhuselekileyo yezigulane ezinembali yesifo samehlo .
Ngaba ukulungele ukuphila ubomi obupheleleyo? Ukufumanisa ukuba inkqubo ye-EVO ICL ikulungele, nceda uqhagamshelane neHoopes Vision ukucwangcisa ukubonisana kwakho kwe-VIP.At Hoopes Vision, izigulane zonwabela irekhodi elihle kakhulu lokhuseleko kunye neziphumo eziqinisekisiweyo, ngelixa uxabisa indlela abavakalelwa ngayo. benze konke abanako ukwenza ulungiso olulungileyo lombono lufikeleleke kwaye lufikeleleke kwizigulane ezinohlahlo lwabiwo-mali olwahlukileyo.


Ixesha lokuposa: May-21-2022