Surgeons Given New FDA LASIK Guidelines
On April 24 the FDA's Ophthalmic Devices Panel heard from both satisfied and dissatisfied LASIK patients, as well as representatives from the American Academy of Ophthalmology and the International Society of Refractive Surgery (ISRS) who spoke about the extensive track record of safety and effectiveness for LASIK.
Following a long day of testimony and presentations, the panel has announced several recommendations for consideration by the FDA, including:
Nobody knows if/when such guidelines will become federal regulations. In the meantime it is worthwhile to share these supplemental guidelines with anyone you know who is considering laser refractive surgery.
Adapted from American Academy of Ophthalmology media release, April 28, 2008
Related Topics: Technorati Tags: eye surgery, LASIK, FDA, vision
Following a long day of testimony and presentations, the panel has announced several recommendations for consideration by the FDA, including:
- Adding photographic illustrations of certain side effects to the FDA Web site
- Better explanation of certain outcomes, such as myopic patients who have LASIK eventually needing reading glasses post surgery
- More understandable information about the potential risks of LASIK (such as dry eye, halos, glare, starbursts, etc.)
- Clearer explanations of disqualifying conditions that might make a patient a poor candidate for LASIK (such as a family history of keratoconus and a history of depression)
- Additional information or guidance in the labeling about postoperative intraocular pressure
- More detailed guidance for lens implant measurement for post LASIK cataract surgery
Nobody knows if/when such guidelines will become federal regulations. In the meantime it is worthwhile to share these supplemental guidelines with anyone you know who is considering laser refractive surgery.
Adapted from American Academy of Ophthalmology media release, April 28, 2008
Related Topics: Technorati Tags: eye surgery, LASIK, FDA, vision
1 Comments:
First off, I must declare that I have a financial interest in this topic.I have created and own the web-based refractive surgery database that will enable post refractive patients to easily store and retrieve critical medical information for their future ocular health. The website is www.safeguardyoursight.com
Around the world, millions of laser refractive surgeries (PRK, LASIK, LASEK, etc.) have been performed since its invention in the 1980s. There are hundreds, if not thousands, of ophthalmologists performing the surgery today. Laser refractive surgery is a safe and effective procedure which has enabled millions of patients worldwide to throw away their glasses and contact lenses.
In order to correct your vision with a laser procedure, the shape and subsequently the thickness of the cornea are subtly altered. These changes alter the dynamics of the cornea and make measuring your eye pressure (critical for glaucoma screening and treatment) inaccurate. The same issue arises when you develop cataracts (everyone eventually develops cataracts) which may need cataract surgery. When an eye doctor removes a cataract, he/she must replace it with an intraocular lens implant. The changes in the cornea throw off the calculations used to choose the correct intraocular lens to be implanted at the time of cataract surgery. Without accurate calculations, the surgeon will be unable correct your vision properly. While other methods to calculate the correct lens power exist, we feel strongly that if your historical information is available to your future cataract surgeon he/she will be better prepared to accurately determine your implant power. As demonstrated in many recent commentaries and peer reviewed articles, many ophthalmologists around the world agree with this opinion. (more references are provided on the website) A recent FDA panel investigating refractive surgery has acknowledged these issues.
(see page 16-17 http://www.fda.gov/ohrms/dockets/ac/08/transcripts/2008-4353t1-04.pdf)
Accurate calculations for glaucoma screening and treatment or cataract surgery require information about the characteristics of your cornea before the laser surgery, as well as the exact type of surgery that was performed. However, very often, this information is not available for your eye care professional to use when it is needed, especially if the laser surgery was performed several years previously. By having your preoperative measurements and surgical treatment data available, your eye care professional will be able to more accurately perform the calculations needed to successfully perform your future cataract procedure. It will also enable him or her to properly monitor your eye pressure throughout your life.
My goal is to educate the public about the long term issues surrounding laser vision correction as well as provide a central database to record the characteristics of your cornea before your surgery; these laser vision parameters will be preserved for important future uses that impact your visual health. When your doctor needs this information in the future, he/she will have easy access to the necessary data with your approval.
Post a Comment