incredible! China's first imported artificial corneal transplant succeeded in Boao operation

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Author : Joe Wong
Update time : 2020-09-28 12:35:46
incredible! China's first imported artificial corneal transplant succeeded in Boao operation

On the afternoon of April 11, 76-year-old Mr. Cai returned to his home in Wenzhou from Boao after successfully transplanting an artificial cornea imported from the United States. He took his grandson's hand and said happily: "I finally saw you, every hair can be seen."

Both eyes became blind due to infectious keratitis. Mr. Cai underwent two left-eye corneal transplants in 2000 and 2008, and both were blind again due to severe rejection. The doctor told him that in this case, the artificial cornea might regain his vision. Since the domestic artificial cornea technology is still immature, although there are artificial cornea products approved for marketing abroad, they have not yet been approved to enter China. Therefore, Mr. Cai can only wait hard.

On April 2, the State Council made the "Decision on Suspending the Implementation of the Regulations on the Supervision and Administration of Medical Devices in the Hainan Boao Lecheng International Medical Tourism Pilot Zone" (hereinafter referred to as the "Decision"), clarifying the urgent clinical needs of medical institutions in the pilot zone Moreover, there is no medical device approved for registration of the same type of product in my country. The Hainan Provincial People's Government implements import approval for use in designated medical institutions.

After the "Decision" was issued, the Boao Super Hospital in the pilot area immediately applied for the import of artificial cornea from the United States. The Hainan Food and Drug Administration has strictly reviewed the approval documents issued by the US FDA for this type of artificial cornea, the manufacturer’s product quality certificate, and global patients. After comprehensive materials such as post-operative adverse event monitoring, prompt approval will be given. The hospital immediately contacted the Massachusetts Eye, Ear, Nose and Throat Hospital, and passed on Mr. Cai's condition data and the size of the cornea needed to be transplanted.

On the morning of April 8, a type I artificial cornea from Boston in the United States was delivered to Boao Super Hospital. In the afternoon of the same day, Chen Wei, director of the team of Professor Qu Jia of the Optometry and Optometry Center of the hospital, performed artificial corneal transplantation for Mr. Cai.

"The left eye is 0.5, and you are completely free of blindness." Chen Wei was very pleased with the results of the visual acuity examination the next day after the operation. He said that this is the first imported artificial corneal transplant in China. Every year, millions of corneal patients in China are waiting for corneal transplantation. Hundreds of thousands of people go to Europe and the United States and other developed countries and regions for treatment. However, the cost of corneal transplantation for patients in the United States is 5-10 times that of imported artificial cornea. Mr. Cai revisited the bright case, let these people see the hope of artificial corneal transplantation in China.

"The implementation of the State Council's first trial policy means that Boao can enjoy international advanced medical technology and the latest medical equipment at low cost for the first time." Chen Wei said.

It is reported that since the release of the "Decision", in addition to Mr. Cai, a four-and-a-half-year-old boy has also enjoyed the benefits of this policy and installed the latest imported cochlear implant.

However, because these urgently needed imported medical devices have not yet undergone clinical trials in China, there may be problems with ethnic differences and risk. Therefore, in addition to patients and their families who have to sign an informed consent form before surgery, the staff of the Hainan Food and Drug Administration also strictly inspected the equipment used before surgery, and will follow up after surgery to strengthen the monitoring of adverse events , To ensure the safety of patients.