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​英訳サンプル:       7​

The U.S. Food and Drug Administration today approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults.

Prior to today’s approval, stitches were the only option for closing a leaking corneal incision after cataract surgery.

“The FDA has approved gels like ReSure for sealing small incisions in other parts of the body, such as the lungs, but this is a first-of-its-kind for the eye,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.
「FDAは肺などの体内のほかの部位における小さな切開部を閉じるReSureのようなゲルをすでに承認していますが、これは眼病治療で用いられる初のものです」と、FDAの生物学的製剤評価研究センター長のChristy Foremanは話します。

Within 20 seconds of applying the liquid to eye tissue, a gel forms that adheres to the eye and seals the incision. The gel gradually breaks down over the course of seven days and is cleared from the body by the eye’s natural tears.

Out the 471 study participants 295 received the ReSure sealant to stop leakage and 176 received a suture.

The study showed that ReSure Sealant was more effective than use of a single suture in preventing incision leakage in the first seven days following cataract surgery.
白内障手術後の最初の7日間に切開部からの漏出を防ぐ上では、ReSure Sealantが一回の縫合術よりも効果的であることが、試験により明らかになりました。

ReSure Sealant subjects and suture subjects reported similar rates of eye pain and sensation of having something in the eye.
眼の痛みや違和感の発生率は、ReSure Sealant群と縫合群でほぼ同じでした。

There were no significant differences in the occurrence of corneal swelling, inflammation, or wound healing among ReSure Sealant subjects and suture subjects.

Researchers did not report any serious device-related adverse events.

One study participant who received ReSure Sealant required sutures to seal a post-operative incision leak.
ReSure Sealant群の1名の参加者は、術後の切開部漏出により縫合術を受けました。

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