美国 FDA 批准 HumanOptics AG 的人工虹膜产品 CustomFlex 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..

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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。

今日美国 FDA 批准的 CustomFlex 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著改善，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。此外，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）。

▲首个人工虹膜 CustomFlex 有望解决患者们的困扰（图片来源：HumanOptics AG 官方网站）

“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。”

A device that replaces the iris through a surgical intervention has just been approved by the U.S. Food and Drug Administration. It’s called the “CustomFlex Artificial Iris,” and the company that received the approval is Clinical Research Consultants, Inc.

The artificial iris has two uses. One of them is to correct vision problems like irises affected by melanomas, birth defects, injuries or people born with albinism that have issues with the irises. The other use is cosmetic, as the artificial iris can come in different colors and it can also repair obvious eye damage.

This is where the director of the Division of Ophthalmic, and Ear, Nose and Throat Devices (Center for Devices and Radiological Health, FDA), Malvinas Eydelman comes to clarify the main purpose of the new device:

”Patients with iris defects may experience severe vision problems, as well as dissatisfaction with the appearance of their eye. Today’s approval of the first artificial iris provides a novel method to treat iris defects, by reducing sensitivity to bright light and glare. It also improves the cosmetic appearance of the eye in patients with aniridia.”

Congenital aniridia is a disorder that affects a person in every 50,000 to 100,000 people in the U.S. The iris can completely or partially be absent in people with this condition.

The artificial iris can be implanted through surgery. Then, the natural structures of the eye should hold it in place. In some cases, it might require stitches.

As for cosmetic use, the artificial iris is made from silicon, and it can have different colors. Not only it can be used to fix vision and structural issues of the eye, but it can also be used for cosmetic purpose.

In clinical tests, 70% of the subjects who were part of the trial. They received the artificial iris and saw a decrease in glare and light sensitivity. The implants had low side effects and some adverse reactions. However, 94% of the participants were happy how the iris looked.

FDA does not recommend the CustomFlex Artificial Iris to patients that have the following health issues: severe chronic inflammation, an abnormal small eye size, chronic glaucoma that is not treated, cataract which was caused by the rubella virus, abnormal or damaged blood vessels on the iris and on the retina, or inner eye infections. The artificial iris is not recommended for pregnant women.