“Cataract surgery may be safer with Laser.” How one could arrive at this conclusion based on a couple of 7 minute presentations is a mystery to us. Based on very preliminary studies that have questionable clinical relevance, these researchers seem all but ready to conclude that laser surgery for cataracts is superior to traditional surgery. It was the story’s job to point out that these views might not represent a totally objective evaluation of the evidence. The story should also have sought out an independent take on the role of this technology for cataract removal — something similar, perhaps, to the views expressed earlier this year by an Australian surgeon in this blog post .
Cataract surgery is the most common procedure performed in the US with over 22 million adults having at least one affected eye. Current surgical methods are safe and effective. So reporting on a new technology should be done carefully and claims of superiority should be viewed with a healthy skepticism. A technology that is expensive to acquire ($4-500,000) that adds to operative time needs to demonstrate a clear and unequivocal advantage prior to adoption. Suggesting superiority based on a brief presentation at an annual meeting is simply not very good reporting.
The story notes that cost is an important barrier to wider use of the laser procedure, since the equipment carries a price tag of $400,000 and insurers currently won’t cover the extra cost. We’ll call this satisfactory, but to make the information more meaningful to readers, the story should have broken down how the cost of an individual laser procedure compares with that of the standard procedure.
We felt that the caveats presented in this article came too late, and were took weak, to provide readers with a balanced perspective on the findings. The headline and first three paragraphs include talk of the laser procedure being “safer” and offering a “benefit” in terms of “less damage to the eye.” There is also the suggestion later down that the procedure might lead to “fewer complications, less inflammation and swelling of the eye, and faster recovery of vision.” Only far down in the piece does it begin to become clear that these studies looked only at surrogate outcomes such as the amount of ultrasound energy applied during the procedure and the number of movements the surgeon performed. As the story belatedly points out, it is uncertain if improvements in these outcomes reflect benefits that actually matter to patients.
The article does not discuss potential harms of femtolaser surgery or mention any adverse effect data reported in the studies being discussed. (Given the brevity of the presentations, it is perhaps not surprising that potential harms were not mentioned.) While there are no data for the use of the femtolaser in cataract surgery, the risks associated with its use are well described when used in vision correction surgery and could have been mentioned here.
The story is based on 7 minute presentations at an annual meeting. The study results have not been subjected to peer review and two of the three physicians quoted have clear ties to the manufacturers of ophthalmic lasers. While there are provisos noted late in the story (including a note about the limited peer review that occurs at meetings), we think that the evidence for the headline and most of the positive comments is a bit overstated.
The story did not engage in overt disease-mongering. However, one might quibble with the fact that the story did not discuss the track record for traditional cataract surgery, which according to NIH is one of the most common, safe, and effective types of surgery performed in the U.S. How important is it for us, given escalating healthcare costs, to have a pricier alternative to a treatment that is already quite successful?
While the story appropriately discloses that an author of one of the studies — Mark Packer, MD — consults for a manufacturer that makes lasers, it did not mention that the lead author of the second study — William Culbertson, MD — also has relationships with laser manufacturers, as disclosed in this recent Medscape CME article (login required). In addition — and more troubling — it did not disclose the fact that an American Academy of Ophthalmology spokesman quoted in the story — James Salz, MD — has received clinical research grants from another laser manufacturer (as disclosed in a different Medscape CME article — login required). Since readers may justifiably assume that Salz is presenting disinterested views on behalf of the association, the failure to discuss his industry ties is a significant shortcoming of the piece.
The story suggests numerous times that laser surgery is likely to be safer and lead to better outcomes compared with traditional surgery. Again, these statements are based on very brief presentations and with limited information. While it may in fact be true, there is no reason to believe that the femtolaser is superior in any way to conventional surgery at this time. But it would have helped to have some idea of the outcomes currently seen with traditional surgery and how frequently complications occur. This information would have helped us judge how much we stand to gain from the new technology. Unfortunately, these details are not provided.
The story states that the femtosecond laser procedure is approved by the FDA, but not widely used in the U.S.
The story did not exaggerate the novelty of this procedure, which is just starting to be evaluated clinically.
The story includes commentary from an expert who wasn’t involved in either study, so we can be sure it wasn’t based entirely on news releases.