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Read Original Story

FDA clears first implantable telescope for vision

Rating

5 Star

FDA clears first implantable telescope for vision

Our Review Summary

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.

 

Why This Matters

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.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

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."

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

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."

Does the story adequately explain/quantify the harms of the intervention?

Satisfactory

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."

Does the story seem to grasp the quality of the evidence?

Satisfactory

Adequate explanation of the study.

Does the story commit disease-mongering?

Satisfactory

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."

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

No truly independent source was quoted, as quotes only came from an FDA opthalmic device chief and from one of the researchers.

Does the story compare the new approach with existing alternatives?

Satisfactory

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."

Does the story establish the availability of the treatment/test/product/procedure?

Satisfactory

The focus of the story is new FDA approval.

Does the story establish the true novelty of the approach?

Satisfactory

The story said it was "first-of-its-kind technology" for a very limited subset of people.

Does the story appear to rely solely or largely on a news release?

Satisfactory

It’s clear that the story didn’t rely solely on a news release.

Total Score: 9 of 10 Satisfactory

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