FDA Yemeje Gahunda ya EVO Visian® ICL, Noneho Ije muri Utah

Niba urambiwe guhangana na myopiya no guhora uhura cyangwa guhuza amaso, EVO Visian ICL ™ (STAAR® Surgical Phakic ICL ya Myopia na Astigmatism) birashobora kuba aribyo wategereje, kandi nyuma yimyaka irenga makumyabiri hanze ya Amerika, amaherezo iraboneka muri Utah kuri Hoopes Vision.
Ku ya 28 Werurwe 2022, uruganda rukomeye rwa STAAR Surgical, rukora uruganda rukomeye rukora linzira zatewe, rwatangaje mu itangazo rigenewe abanyamakuru ko Ikigo cy’Amerika gishinzwe ibiryo n’ibiyobyabwenge (FDA) cyemeje EVO / EVO + Visian® Implantable Collamer® Lens (EVO) nka Myopia itekanye. hamwe na astigmatism hamwe nubuvuzi bwiza muri Amerika
Caren Mason, perezida akaba n'umuyobozi mukuru wa STAAR Surgical, yagize ati: "Lens zirenga miliyoni 1 zatewe n'abaganga bo hanze ya Amerika, naho 99.4% by'abarwayi ba EVO mu bushakashatsi bavuze ko bazongera kubagwa."
Ati: “Igurishwa ry’inzira za EVO hanze y’Amerika ryiyongereyeho 51% mu 2021, rikubye inshuro zirenga ebyiri kuva mu 2018, ibyo bikaba byerekana ko abarwayi ndetse n’abafatanyabikorwa bacu babaga muri EVO ari uburyo bwiza bwo gukosora no gukemura ibibazo.”

Menyesha igikoresho cyo gukuraho Lens

Menyesha igikoresho cyo gukuraho Lens
Ubu buryo bukora neza umunsi umwe wo gukosora iyerekwa burashobora kurangira muminota igera kuri 20-30.Ntabwo aribwo buryo bwihuse kandi butababaza, EVO ICL ifite ibyiza byigihe cyo gukira vuba, ntabwo ikeneye lens ya contact hamwe nikirahure, kandi ikanozwa intera nijoro iyerekwa hafi ijoro ryose - kubantu benshi bababajwe ninteguza cyangwa ibirahure, Inzozi zabaye impamo.
Myopia, izwi kandi ku izina rya “kurebera kure,” ni kimwe mu bintu bikunze kugaragara ku isi hose, aho umuntu ashobora kubona ibintu byegeranye neza, ariko ibintu bya kure bikagaragara ko bidasobanutse. Dukurikije ikigo cy'igihugu gishinzwe amaso (NEI), “Ubushakashatsi bwinshi bwerekana ko U ubwiyongere bwa myopiya buragenda bwiyongera muri Amerika ndetse no ku isi hose, kandi abashakashatsi bategereje ko iyi nzira izakomeza mu myaka mirongo iri imbere. ”
Raporo ya NEI yagize ati: Myopia ibaho iyo amaso y'umuntu akuze cyane kuva imbere kugeza inyuma, bigatuma urumuri rwangirika cyangwa “kugoreka” nabi. Abanyamerika bagera kuri 41,6 ku ijana ntibareba kure, “bivuye kuri 25 ku ijana mu 1971”.
STAAR Surgical ivuga ko miliyoni 100 z'abantu bakuze bo muri Amerika bafite imyaka iri hagati ya 21 na 45 bashobora kuba abakandida ba EVO, lens yihanganira neza ikosora icyerekezo cy'umuntu, ikabemerera kubona ibintu bya kure.
Lens ya EVO Visian izwi kandi nka "Implantable Collamer® Lens" .Ibikoresho bikozwe mubikoresho byihariye bya Collamer bya STAAR Surgical.Birimo ibintu bike bya kolagene isukuye naho ibindi bikozwe mubintu bisa biboneka mumurongo woroshye wo guhuza.Collamer iroroshye .
Mbere yo kubagwa kwa EVO Visian ICL, umuganga wawe azakora ibizamini byinshi kugirango apime ibintu bidasanzwe biranga ijisho ryawe. Ako kanya mbere yo kubagwa, umuganga wawe azakoresha ibitonyanga by'amaso kugirango yagure abanyeshuri bawe kandi ahumure amaso.Ubutaha, lens ya EVO ICL izaba kuzinga no kwinjizwa mu gufungura gato mu gihimba cya cornea.

Menyesha igikoresho cyo gukuraho Lens

Menyesha igikoresho cyo gukuraho Lens
Nyuma yo gushyiramo lens, umuganga azagira ibyo ahindura kugirango akemure neza neza lens. Lens izashyirwa neza inyuma ya iris (igice cyamabara yijisho) no imbere yinzira karemano.Igihe lens iba ushyizwemo, wowe nabandi ntushobora kubibona, kandi lens yoroshye, yoroheje ihuza neza nijisho ryawe risanzwe.
Mu myaka irenga 20, lens ya Collamer yatewe na STAAR yagiye ifasha abarwayi kugera ku cyerekezo cyiza, kubabohora mubirahuri no guhuza amakuru, hanyuma, EVO ICL yakiriye FDA kubarwayi bo muri Amerika.
Umuyobozi mukuru w’ubuvuzi muri STAAR Surgical, Scott D. Barnes yagize ati: "Twishimiye guha EVO abaganga n’abarwayi bo muri Amerika bashaka uburyo bwagaragaye bwo kubona amadarubindi yo mu rwego rwo hejuru, indorerwamo zandikirwa, cyangwa gukosora icyerekezo cya laser.""Iri tangazo ry'uyu munsi ni ingenzi cyane, Kubera ko ubwiyongere bwa myopiya bugenda bwiyongera vuba, ingamba za COVID zitera izindi ngorane ku bambara amadarubindi na / cyangwa lens.
Ati: “EVO yongeyeho igikoresho cy'ingenzi ku baganga b'amaso bashaka gufasha mu kuzamura imibereho y'umurwayi.Bitandukanye na LASIK, lens ya EVO yongewe mumaso yumurwayi binyuze muburyo bwihuse bwo kubaga, bitabaye ngombwa ko hakurwaho ingirangingo.Mubyongeyeho, niba ubishaka, abaganga barashobora gukuramo lens ya EVO.Ibyavuye mu igeragezwa ry’amavuriro duherutse muri Amerika birahuye n’inzira zirenga miliyoni imwe za EVO zatewe ku isi hose. ”
EVO nuburyo bwemewe na FDA bwo gukosora iyerekwa kubarwayi ba myopique bafite cyangwa badafite astigmatism bashaka gukuraho ibikenerwa byikirahure cyangwa lens ya contact.Mu gihe EVO ari igisubizo kirambye cyo gukuraho abarwayi kubibazo bya buri munsi byo guhura no kwambara ibirahure, birashoboka ko EVO idakwiriye abanduye LASIK, kuko inzira itashyizweho nkuburyo bwizewe kubarwayi bafite amateka yindwara zamaso.
Witeguye kubaho ubuzima bwuzuye? Kugirango umenye niba gahunda ya EVO ICL ibereye kuri wewe, nyamuneka hamagara Hoopes Vision kugirango utegure inama zawe VIP.Ku cyerekezo cya Hoopes, abarwayi bishimira amateka meza yumutekano nibisubizo byagaragaye, mugihe bashima uko babikora kora ibishoboka byose kugirango icyerekezo gikosorwe gikosorwe kandi giherereye kubarwayi bafite bije zitandukanye.


Igihe cyo kohereza: Gicurasi-21-2022