This is a story on a new medical device, an implantable collamer lens (ICL), which is never mentioned by name in the story. It was recently approved by the FDA for the treatment of fairly severe nearsightedness. While the story mentions its limited use (only for those with serious nearsightedness) and the risks associated with its use (infection, glaucoma, and cataract), the story provides little information that would be useful for an individual interested in the weighing the options available for treatment. Where is the clinical trial data? For a story that profiles a 23-year old patient, it is noteworthy that there is no information about what’s known or not known about long-term use.
Lists cost of surgery at $3,500 per eye and notes it is not typically covered by insurance
No quantification of benefit. FDA new device approval (see above) had some of this.
Risks of harms (infection, glaucoma, and cataract) are listed but no rates are presented. Wouldn’t readers want to know how often these occur? The story presents a case of a 23 year old patient, which seems to demand information about the long term outcomes, but that info is not given (how long patients have been followed, how age-related changes in vision are affected by presence of the device, etc.).
No mention of the clinical trials. The FDA new device approval mentioned “a clinical study of 294 patients who had the device implanted, 95% of whom had 20/40 or better (considered standard vision to get a driver’s license), and 59% had 20/20 or better after 3 years”
Does not provide any context for the prevalence of myopia for which this treatment might be applicable. On the other hand, it at least points out that it is for treatment of more severe nearsightedness. But who fits in that category? How many?
Two “true believer” patient quotes are included along with comments from an enthusiastic ophthalmologist. Are there other opinions? The story provides no evidence of a search for other perspectives.
Reference is made to the intraocular lens implant that FDA approved in 2004 for treatment of similar range of myopia; as well as LASIK surgery, another procedure which can be used to treat the problem. The advantage of this new device as compared with LASIK is said to be elimination of the halo some experience at night; the advantage over the IOL is a smaller incision is used (mentioned) and less associated corneal endothelial loss because of differences in placement between the two devices (not mentioned). However – there is no clear hierarchy of treatment presented, i.e. glasses or contact lenses as first choice options; laser surgery for individuals with mild nearsightedness who want to avoid corrective vision devices. For those with more severe nearsightedness, this device represents a new option.
Story mentions that only a handful of ophthalmologists have begun using it but that by April, it is expected to be widely available. (according to whom?) Mention is made of its FDA approval in December 2005.
This article reports on an implantable collamer lens, which is a newly FDA approved medical device for correction of myopia (-3 to -15 diopters with only limited amount of astigmatism) or reduction of myopia (-15 to -20 D with limited astigmatism).
We can’t be sure if the story relied solely on a news release.