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美国FDA批准人工虹膜 有望解决患者困扰

2018-05-31 佚名 药明康德

人工虹膜的为虹膜缺陷带来了全新的疗法,能降低对亮光的敏感度,改善无虹膜症患者的眼睛外观。

人工虹膜的为虹膜缺陷带来了全新的疗法,能降低对亮光的敏感度,改善无虹膜症患者的眼睛外观。

5月31日,美国FDA批准人工虹膜上市,治疗由于先天性遗传缺陷或后天损伤,导致虹膜缺失或受损的成人和儿童患者。值得一提的是,这也是美国FDA批准的首款独立虹膜假体。

虹膜是眼睛的重要组成部分,能控制进入眼睛的光线量。然而在美国,大约每5万-10万人里,就有一人不幸患有先天性无虹膜症,导致严重的视觉问题。此外,由于白化病、创伤、或是手术等原因,一些患者的虹膜会出现受损。对于这两类患者来说,一款人工虹膜产品将为他们的世界带来重大不同。

美国FDA批准的人工虹膜就有望解决患者们的困扰。这款虹膜由可折叠的硅制医疗材料制成,可根据每名患者的需求定制尺寸与大小。它的安装也极为便捷——医生们只要切开一个小口,将人工虹膜插入并展开即可。这层人工虹膜会被眼球的解剖结构自然支撑。如有需求,也可以将其缝合固定。

这款产品的安全性和有效性在一项非随机的临床试验中得到了确认。该试验一共招募了389名成人与儿童患者,并让这些患者汇报使用人工虹膜产品后,对光敏感度的变化、健康相关生活质量的改善、以及对假体的满意程度。研究表明,超过70%的患者表示对强光的敏感度有显着改善,生活质量也有所提升。此外,有94%的患者对人工虹膜的外观感到满意。本研究也表明,与该人工虹膜以及手术过程相关的副作用较少。基于这些结果,美国FDA决定批准其上市。而在之前,这款产品也曾获“突破性器械认定”(Breakthrough Device designation)。

“虹膜有缺陷的患者可能经历严重的视觉问题,也会对眼睛的外观感到不满意,”美国FDA医疗器械与放射健康中心,眼耳鼻喉设备部主任Malvina Eydelman博士说道:“今日首个人工虹膜的批准为虹膜缺陷带来了全新的疗法,能降低对亮光的敏感度。它也能改善无虹膜症患者的眼睛外观。”

我们期待这款产品能早日为需要的患者带来生活上的改善。

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    2018-08-10 bugit
  2. 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    2019-04-06 LSJ123
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  4. 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createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLCclExeQ6LOGMD4dTsia4Ty4HtZCxRmG5vO5XIKfKX3a3vusfhHSej4Iib517vmhFW7RQgh7bpDp1yw/0, createdBy=50951609779, createdName=baihao215, createdTime=Fri Jun 01 07:23:59 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320461, encodeId=3fa1320461eb, content=学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Jun 01 07:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320450, encodeId=5b283204507d, content=一起学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/TDiaAWyicHgedzX3wKo3qcxudVJib7AfibfvNeufHRF2jG3Bw8MmZyWjIhtBV1mpJI7Sy9n7RcBKK5t3CuOKuOFxkg/0, createdBy=dd702206933, createdName=wzb521zf, createdTime=Fri Jun 01 06:44:09 CST 2018, time=2018-06-01, status=1, ipAttribution=)]
    2018-06-02 yfjms

    学习

    0

  5. 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createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/TDiaAWyicHgedzX3wKo3qcxudVJib7AfibfvNeufHRF2jG3Bw8MmZyWjIhtBV1mpJI7Sy9n7RcBKK5t3CuOKuOFxkg/0, createdBy=dd702206933, createdName=wzb521zf, createdTime=Fri Jun 01 06:44:09 CST 2018, time=2018-06-01, status=1, ipAttribution=)]
    2018-06-01 飘飘爱

    很好

    0

  6. 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createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/TDiaAWyicHgedzX3wKo3qcxudVJib7AfibfvNeufHRF2jG3Bw8MmZyWjIhtBV1mpJI7Sy9n7RcBKK5t3CuOKuOFxkg/0, createdBy=dd702206933, createdName=wzb521zf, createdTime=Fri Jun 01 06:44:09 CST 2018, time=2018-06-01, status=1, ipAttribution=)]
    2018-06-01 衣带渐宽

    学习

    0

  7. 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createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLCclExeQ6LOGMD4dTsia4Ty4HtZCxRmG5vO5XIKfKX3a3vusfhHSej4Iib517vmhFW7RQgh7bpDp1yw/0, createdBy=50951609779, createdName=baihao215, createdTime=Fri Jun 01 07:23:59 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320461, encodeId=3fa1320461eb, content=学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Jun 01 07:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320450, encodeId=5b283204507d, content=一起学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/TDiaAWyicHgedzX3wKo3qcxudVJib7AfibfvNeufHRF2jG3Bw8MmZyWjIhtBV1mpJI7Sy9n7RcBKK5t3CuOKuOFxkg/0, createdBy=dd702206933, createdName=wzb521zf, createdTime=Fri Jun 01 06:44:09 CST 2018, time=2018-06-01, status=1, ipAttribution=)]
    2018-06-01 明月清辉

    谢谢分享.学习了

    0

  8. 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createdBy=7a041951742, createdName=衣带渐宽, createdTime=Fri Jun 01 14:35:10 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320513, encodeId=c0e73205138f, content=谢谢分享.学习了, beContent=null, objectType=article, channel=null, level=null, likeNumber=113, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/NUyjXTCJjo6Nx0VGA4QMDzOP8oAgnV4h51EjSfehJ9QxyiaSmw8PB56BhY8KXFSxHCibXrzcy4abrzSibXQPxJ9kzrLcJyhhB8a/0, createdBy=1d3b1672603, createdName=明月清辉, createdTime=Fri Jun 01 08:05:43 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320476, encodeId=f49a3204e688, content=Amazing, beContent=null, objectType=article, channel=null, level=null, likeNumber=84, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLCclExeQ6LOGMD4dTsia4Ty4HtZCxRmG5vO5XIKfKX3a3vusfhHSej4Iib517vmhFW7RQgh7bpDp1yw/0, createdBy=50951609779, createdName=baihao215, createdTime=Fri Jun 01 07:23:59 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320461, encodeId=3fa1320461eb, content=学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Jun 01 07:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320450, encodeId=5b283204507d, content=一起学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/TDiaAWyicHgedzX3wKo3qcxudVJib7AfibfvNeufHRF2jG3Bw8MmZyWjIhtBV1mpJI7Sy9n7RcBKK5t3CuOKuOFxkg/0, createdBy=dd702206933, createdName=wzb521zf, createdTime=Fri Jun 01 06:44:09 CST 2018, time=2018-06-01, status=1, ipAttribution=)]
    2018-06-01 baihao215

    Amazing

    0

  9. 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createdAvatar=https://wx.qlogo.cn/mmopen/ajNVdqHZLLCclExeQ6LOGMD4dTsia4Ty4HtZCxRmG5vO5XIKfKX3a3vusfhHSej4Iib517vmhFW7RQgh7bpDp1yw/0, createdBy=50951609779, createdName=baihao215, createdTime=Fri Jun 01 07:23:59 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320461, encodeId=3fa1320461eb, content=学习了.谢谢分享, beContent=null, objectType=article, channel=null, level=null, likeNumber=54, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=, createdBy=7c592194322, createdName=1209e435m98(暂无昵称), createdTime=Fri Jun 01 07:03:00 CST 2018, time=2018-06-01, status=1, ipAttribution=), GetPortalCommentsPageByObjectIdResponse(id=320450, encodeId=5b283204507d, content=一起学习学习, beContent=null, objectType=article, channel=null, level=null, likeNumber=46, replyNumber=0, topicName=null, topicId=null, topicList=[], attachment=null, authenticateStatus=null, createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/TDiaAWyicHgedzX3wKo3qcxudVJib7AfibfvNeufHRF2jG3Bw8MmZyWjIhtBV1mpJI7Sy9n7RcBKK5t3CuOKuOFxkg/0, createdBy=dd702206933, createdName=wzb521zf, createdTime=Fri Jun 01 06:44:09 CST 2018, time=2018-06-01, status=1, ipAttribution=)]
    2018-06-01 1209e435m98(暂无昵称)

    学习了.谢谢分享

    0

  10. 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createdAvatar=https://wx.qlogo.cn/mmopen/vi_32/TDiaAWyicHgedzX3wKo3qcxudVJib7AfibfvNeufHRF2jG3Bw8MmZyWjIhtBV1mpJI7Sy9n7RcBKK5t3CuOKuOFxkg/0, createdBy=dd702206933, createdName=wzb521zf, createdTime=Fri Jun 01 06:44:09 CST 2018, time=2018-06-01, status=1, ipAttribution=)]
    2018-06-01 wzb521zf

    一起学习学习

    0

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