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是否决定做手术,以下是FDA给出的忠告!!

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发表于 2008-4-29 15:55:36 | 显示全部楼层 |阅读模式
自己翻译一下吧,也可看网址:http://www.fda.gov/cdrh/LASIK/risks.htm


What are the risks and how can I find the right doctor for me?

Most patients are very pleased with the results of their refractive surgery. However, like any other medical procedure, there are risks involved. That's why it is important for you to understand the limitations and possible complications of refractive surgery.

Before undergoing a refractive procedure, you should carefully weigh the risks and benefits based on your own personal value system, and try to avoid being influenced by friends that have had the procedure or doctors encouraging you to do so.

Some patients lose vision. Some patients lose lines of vision on the vision chart that cannot be corrected with glasses, contact lenses, or surgery as a result of treatment.
  
Some patients develop debilitating visual symptoms. Some patients develop glare, halos, and/or double vision that can seriously affect nighttime vision. Even with good vision on the vision chart, some patients do not see as well in situations of low contrast, such as at night or in fog, after treatment as compared to before treatment.
  
You may be under treated or over treated. Only a certain percent of patients achieve 20/20 vision without glasses or contacts. You may require additional treatment, but additional treatment may not be possible. You may still need glasses or contact lenses after surgery. This may be true even if you only required a very weak prescription before surgery. If you used reading glasses before surgery, you may still need reading glasses after surgery.
  
Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. This condition may be permanent. Intensive drop therapy and the use of plugs or other procedures may be required.
  
Results are generally not as good in patients with very large refractive errors of any type. You should discuss your expectations with your doctor and realize that you may still require glasses or contacts after the surgery.
  
For some farsighted patients, results may diminish with age. If you are farsighted, the level of improved vision you experience after surgery may decrease with age. This can occur if your manifest refraction (a vision exam with lenses before dilating drops) is very different from your cycloplegic refraction (a vision exam with lenses after dilating drops).
  
Long-term data is not available. LASIK is a relatively new technology. The first laser was approved for LASIK eye surgery in 1998. Therefore, the long-term safety and effectiveness of LASIK surgery is not known.







What are the risks and how can I find the right doctor for me?

Most patients are very pleased with the results of their refractive surgery. However, like any other medical procedure, there are risks involved. That's why it is important for you to understand the limitations and possible complications of refractive surgery.

Before undergoing a refractive procedure, you should carefully weigh the risks and benefits based on your own personal value system, and try to avoid being influenced by friends that have had the procedure or doctors encouraging you to do so.

Some patients lose vision. Some patients lose lines of vision on the vision chart that cannot be corrected with glasses, contact lenses, or surgery as a result of treatment.
  
Some patients develop debilitating visual symptoms. Some patients develop glare, halos, and/or double vision that can seriously affect nighttime vision. Even with good vision on the vision chart, some patients do not see as well in situations of low contrast, such as at night or in fog, after treatment as compared to before treatment.
  
You may be under treated or over treated. Only a certain percent of patients achieve 20/20 vision without glasses or contacts. You may require additional treatment, but additional treatment may not be possible. You may still need glasses or contact lenses after surgery. This may be true even if you only required a very weak prescription before surgery. If you used reading glasses before surgery, you may still need reading glasses after surgery.
  
Some patients may develop severe dry eye syndrome. As a result of surgery, your eye may not be able to produce enough tears to keep the eye moist and comfortable. This condition may be permanent. Intensive drop therapy and the use of plugs or other procedures may be required.
  
Results are generally not as good in patients with very large refractive errors of any type. You should discuss your expectations with your doctor and realize that you may still require glasses or contacts after the surgery.
  
For some farsighted patients, results may diminish with age. If you are farsighted, the level of improved vision you experience after surgery may decrease with age. This can occur if your manifest refraction (a vision exam with lenses before dilating drops) is very different from your cycloplegic refraction (a vision exam with lenses after dilating drops).
  
Long-term data is not available. LASIK is a relatively new technology. The first laser was approved for LASIK eye surgery in 1998. Therefore, the long-term safety and effectiveness of LASIK surgery is not known.






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发表于 2008-4-29 15:55:37 | 显示全部楼层



Finding the Right Doctor
If you are considering refractive surgery, make sure you:

Compare. The levels of risk and benefit vary slightly not only from procedure to procedure, but from device to device depending on the manufacturer, and from surgeon to surgeon depending on their level of experience with a particular procedure.
Don't base your decision simply on cost and don't settle for the first eye center, doctor, or procedure you investigate. Remember that the decisions you make about your eyes and refractive surgery will affect you for the rest of your life.
Be wary of eye centers that advertise, "20/20 vision or your money back" or "package deals." There are never any guarantees in medicine.
Read. It is important for you to read the patient handbook provided to your doctor by the manufacturer of the device used to perform the refractive procedure. Your doctor should provide you with this handbook and be willing to discuss his/her outcomes (successes as well as complications) compared to the results of studies outlined in the handbook.
Even the best screened patients under the care of most skilled surgeons can experience serious complications.

During surgery. Malfunction of a device or other error, such as cutting a flap of cornea through and through instead of making a hinge during LASIK surgery, may lead to discontinuation of the procedure or irreversible damage to the eye.
After surgery. Some complications, such as migration of the flap, inflammation or infection, may require another procedure and/or intensive treatment with drops. Even with aggressive therapy, such complications may lead to temporary loss of vision or even irreversible blindness.


If you are considering refractive surgery, make sure you:

Compare. The levels of risk and benefit vary slightly not only from procedure to procedure, but from device to device depending on the manufacturer, and from surgeon to surgeon depending on their level of experience with a particular procedure.
Don't base your decision simply on cost and don't settle for the first eye center, doctor, or procedure you investigate. Remember that the decisions you make about your eyes and refractive surgery will affect you for the rest of your life.
Be wary of eye centers that advertise, "20/20 vision or your money back" or "package deals." There are never any guarantees in medicine.
Read. It is important for you to read the patient handbook provided to your doctor by the manufacturer of the device used to perform the refractive procedure. Your doctor should provide you with this handbook and be willing to discuss his/her outcomes (successes as well as complications) compared to the results of studies outlined in the handbook.
Even the best screened patients under the care of most skilled surgeons can experience serious complications.

During surgery. Malfunction of a device or other error, such as cutting a flap of cornea through and through instead of making a hinge during LASIK surgery, may lead to discontinuation of the procedure or irreversible damage to the eye.
After surgery. Some complications, such as migration of the flap, inflammation or infection, may require another procedure and/or intensive treatment with drops. Even with aggressive therapy, such complications may lead to temporary loss of vision or even irreversible blindness.



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发表于 2008-4-29 15:55:38 | 显示全部楼层



以上有些东西是美国医院被要求要做的,比如给出各种情况、数据的资料手册,如果不跟就是违法。当然,中国现在还没有类似要求,阅读时应该要注意两个国家的不同点。希望阳光能按美国医院的要求或以其标准去做,给我们这些近视患者一个更好的就医环境。



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发表于 2008-4-29 15:55:39 | 显示全部楼层



翻译出来的东东怪怪的,希望有标准一点的中文翻译呀!



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发表于 2008-4-29 15:55:40 | 显示全部楼层



恩...现在是咱们这里只知道有风险,但是没有可靠的数据来确知风险是多少.





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发表于 2008-4-29 15:55:41 | 显示全部楼层



我觉得这么大一个手术”工程“,虽说只有十几分钟,可可能就关系到很多人的终身幸福了啊!我也觉得医院有必要总结这些数据,而且,医院的教授什么的,要写论文啊~或者什么研究报告之类的难道不需要这些数据???并不能节省了这么一点小钱而耽误了以后的光明前途啊!!!网管,向医院反映啊!!!



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发表于 2008-4-29 15:55:42 | 显示全部楼层



哇 真是怪



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发表于 2008-4-29 15:55:43 | 显示全部楼层



凡事有利就有弊,这些不过就像一般术前协议一样,提醒你风险的存在,再提醒你合理地选择医院和医生。技术确实是新的,没有太多长远的数据可供参考,如果没有人敢做,这项数据就永远为零。但愿10年、20年后,我可以为其他患者提供一组比较POSITIVE的数据。:)
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