FDA e Amohela Lenaneo la EVO Visian® ICL, Joale le Tla Utah

Haeba u khathetse ke ho sebetsana le myopia le ho lula u ntse u shebana le mahlo, EVO Visian ICL™ (STAAR® Surgical Phakic ICL bakeng sa Myopia le Astigmatism) e kanna ea ba sona seo esale u se emetse, mme kamora lilemo tse fetang Mashome US, qetellong e fumaneha Utah ho Hoopes Vision.
Ka la 28 Hlakubele 2022, Khamphani ea STAAR Surgical Company, e leng moetsi ea ka sehloohong oa lilense tse kenngoeng, e phatlalalitse phatlalatsong ea boralitaba hore US Food and Drug Administration (FDA) e amohetse EVO/EVO+ Visian® Implantable Collamer® Lens (EVO) e le Myopia e bolokehileng. ka astigmatism le ntle le liphekolo tse sebetsang US
"Lilense tsa EVO tse fetang limilione tse 1 li kentsoe ke lingaka tse ka ntle ho US, 'me 99.4% ea bakuli ba EVO phuputsong e itseng ba tla etsoa opereishene hape," ho boletse Caren Mason, mopresidente le CEO oa STAAR Surgical.
"Lithekiso tsa lilense tsa EVO kantle ho US li eketsehile ka 51% ka 2021, ho feta habeli ho tloha ka 2018, ho bonts'a khetho e ntseng e eketseha ea bakuli le balekane ba rona ba ngaka e buoang bakeng sa EVO e le khetho ea pele bakeng sa khalemelo e matla le litharollo tse kholo."

Ikopanye le Sesebelisoa sa ho Tlosa Lense

Ikopanye le Sesebelisoa sa ho Tlosa Lense
Ts'ebetso ena e sebetsang haholo ea ho lokisa pono ea letsatsi le le leng e ka phethoa hoo e ka bang metsotso e 20-30. Hase feela hore ts'ebetso e potlakile ebile e se na bohloko, EVO ICL e na le molemo oa nako ea ho hlaphoheloa ka potlako, ha ho hlokahale lilense le likhalase, 'me e ntlafalitsoe. ho bona sebaka le bosiu hoo e ka bang ka bosiu bo le bong - ho batho ba bangata ba ferekantsoeng ke lense kapa likhalase, Toro e phethahala.
Myopia, eo hape e tsejoang e le "ho bonela haufi," ke e 'ngoe ea maemo a tloaelehileng a pono lefatšeng ka bophara, moo motho a ka bonang lintho tse haufi ka ho hlaka, empa lintho tse hōle li bonahala li le lerootho. ho ata ha myopia ho ntse ho eketseha United States le lefatšeng ka bophara, ’me bafuputsi ba lebelletse hore mokhoa ona o tla tsoela pele ka mashome a lilemo a tlang.”
Myopia e etsahala ha mahlo a motho a hōla haholo ho tloha ka pele ho ea morao, a etsa hore leseli le kobehe kapa le “kobehe” ka tsela e fosahetseng. Hoo e ka bang karolo ea 41,6 lekholong ea Maamerika e na le pono e haufi, “ho tloha ho karolo ea 25 lekholong ka 1971,” tlaleho ea NEI e boletse.
STAAR Surgical e hakanya hore batho ba baholo ba US ba limilione tse 100 ba pakeng tsa lilemo tse 21 le 45 e kanna ea ba batho ba ka bang teng bakeng sa EVO, lense e mamelloang hantle e lokisang pono ea motho ea hole, e ba lumellang ho bona lintho tse hole.
Lilense tsa EVO Visian li boetse li tsejoa e le "Implantable Collamer® Lenses".Lenses li entsoe ka thepa ea STAAR Surgical's proprietary Collamer.E na le collagen e hloekisitsoeng e nyenyane 'me e setseng e entsoe ka thepa e tšoanang e fumanoang ka lilense tse bonolo.Collamer e bonolo. , e tsitsitseng, e tenyetseha ebile e lumellana le biocompatible.Collamer e na le histori ea tšebeliso e atlehileng ea intraocular lefatšeng ka bophara 'me e ipakile e le lisebelisoa tsa lense tsa mahlo tse phutholohileng le tse sebetsang hantle.
Pele ho buuoa ka EVO Visian ICL, ngaka ea hau e tla etsa letoto la liteko ho lekanya litšobotsi tse ikhethang tsa leihlo la hau.Hang-hang pele ho buuoa, ngaka ea hau e tla sebelisa marotholi a mahlo ho fokotsa bana ba hao le ho senya mahlo a hao.E latelang, lense ea EVO ICL e tla ba menahaneng le ho kenyeletsoa lesobeng le lenyane la setho sa cornea.

Ikopanye le Sesebelisoa sa ho Tlosa Lense

Ikopanye le Sesebelisoa sa ho Tlosa Lense
Ka mor'a ho kenya lense, ngaka e tla etsa liphetoho leha e le life tse hlokahalang ho netefatsa boemo bo nepahetseng ba lense.Lense e tla behoa ka thata ka morao ho iris (karolo e mebala ea leihlo) le ka pel'a lense ea tlhaho.Hang ha lense e le e kentsoe, uena le ba bang ha le e bone, 'me lense e bonolo, e tenyetsehang e lumellana hantle le leihlo la hau la tlhaho.
Ka lilemo tse fetang 20, lilense tsa STAAR tsa Collamer tse kentsoeng esale li thusa bakuli ho fumana pono e ntle, li ba lokolla likhalaseng le lilenseng tsa ho ikopanya, 'me qetellong, EVO ICL e fumane tumello ea FDA bakeng sa bakuli ba US.
"Re thabela ho fana ka EVO ho lingaka tse buoang tsa US le bakuli ba batlang khetho e tiisitsoeng bakeng sa likhalase tsa mahlo tsa boleng bo phahameng, li-contact lenses, kapa ho lokisa pono ea laser," ho boletse Scott D. Barnes, MD, Mookameli oa Bongaka oa STAAR Surgical."Phatlalatso ea kajeno e bohlokoa haholo, Hobane ts'oaetso ea myopia e ntse e eketseha ka potlako, litemoso tsa COVID li baka mathata a eketsehileng ho ba roala likhalase le/kapa lilense tsa ho ikopanya.
"EVO e eketsa sesebelisoa sa bohlokoa ho lingaka tsa mahlo tse batlang ho thusa ho ntlafatsa boleng ba bophelo ba mokuli.Ho fapana le LASIK, lilense tsa EVO li kenngoa ka leihlong la mokuli ka ho buuoa ka potlako, ntle le tlhokahalo ea ho tlosa lisele tsa cornea.Ho phaella moo, haeba ho hlokahala, lingaka li ka tlosa lilense tsa EVO.Liphetho tsa liteko tsa rona tsa bongaka tsa morao-rao Amerika li lumellana le lilense tsa EVO tse fetang milione o le mong tse kentsoeng lefatšeng ka bophara.
EVO ke khetho e amohelehang ea FDA ea ho lokisa pono bakeng sa bakuli ba myopic kapa ntle le astigmatism ba batlang ho felisa tlhokahalo ea likhalase kapa li-lenses tsa ho kopana. ho ka etsahala hore EVO ha e tšoanelehe bakeng sa ba kileng ba feta LASIK, kaha mokhoa ona ha o e-s'o thehoe e le mokhoa o sireletsehileng ho bakuli ba nang le histori ea lefu la mahlo .
Na u se u itokiselitse ho phela bophelo bo felletseng?Ho fumana hore na lenaneo la EVO ICL le u loketse, ka kopo ikopanye le Hoopes Vision ho hlophisa lipuisano tsa hau tsa VIP.Ho Hoopes Vision, bakuli ba natefeloa ke rekoto e ntle haholo ea polokeho le liphetho tse netefalitsoeng, ha ba ntse ba ananela mokhoa oo ba o etsang. etsa sohle seo ba ka se khonang ho etsa hore tokiso e nepahetseng ea pono e fihlellehe le hore bakuli ba nang le litekanyetso tse fapaneng ba ka khona ho fihlelleha.


Nako ea poso: May-21-2022