A very careful report on progress for this vision problem, emphasizing potential harms, the limited subset of people who might benefit, and costs. Nice job.
This is a fresh example of how stories about new technologies can address our criteria of what we think it’s important for consumers to know – and to do so in a reasonably short story.
The story explains that "is seeking Medicare coverage for the surgery and rehab costs, a package that it calls CentraSight. The company wouldn’t estimate total costs but said the device itself costs $15,000."
Very clear on this. The story said: "the FDA said 90 percent of telescope recipients had their vision improve by at least two lines on an eye chart, and three-quarters went from severe to moderate vision impairment. …’We’re not giving people back 20-year-old eyes,’ cautioned ophthalmic surgeon Dr. Kathryn Colby."
The story was very clear about potential harms: "In fact, the FDA took the highly unusual step of requiring that patients and their surgeons sign a detailed "acceptance of risk agreement" before surgery, acknowledging potential side effects — including corneal damage and worsened vision — and the need for lots of testing to determine who’s a candidate. … Concern about damage to the inside lining of the cornea, the eye’s clear front covering that helps focus light, held up FDA approval for several years. In that study, 10 eyes had serious corneal swelling, five that required corneal transplants. FDA’s Eydelman said the company proposed candidate restrictions to minimize that risk, and will study how an additional 770 recipients fare after sales begin."
Adequate explanation of the study.
No disease-mongering. In fact, the story is quite clear that "it’s only for a subset of the nearly 2 million Americans with advanced macular degeneration…Those 75 and older, with a certain degree of vision loss, who also need a cataract removed."
No truly independent source was quoted, as quotes only came from an FDA opthalmic device chief and from one of the researchers.
The story let an FDA spokesman put the development in perspective: "There’s little to help such advanced patients today aside from difficult-to-use handheld or glasses-mounted telescopes, while the new implanted telescope — smaller than a pea — can improve quality of life for the right candidate, said Dr. Malvina Eydelman, FDA’s ophthalmic devices chief."
The focus of the story is new FDA approval.
The story said it was "first-of-its-kind technology" for a very limited subset of people.
It’s clear that the story didn’t rely solely on a news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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