Citing “uncompromising commitment to patient safety,” Alcon has announced an immediate, voluntary withdrawal of all versions of the CyPass micro-stent from the global market and advises surgeons to immediately cease further implantation of the device.
According to a company press release, the decision was based on safety data from the COMPASS-XT study, which found a statistically significant difference in endothelial cell loss at 5 years after surgery in patients who received the device in conjunction with cataract surgery compared to those who underwent cataract surgery alone.
The CyPass micro-stent has been FDA approvedfor use in conjunction with cataract surgery for treatment of mild-to-moderate primary open-angle glaucoma since July 2016. That approval was based on 2-year results of the COMPASS study, which “were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss,” according to the release.
The company will contact ophthalmic surgeons directly with recommendations how to proceed, according to the release.
“Although we are removing the product from the market now out of an abundance of caution, we intend to partner with the FDA and other regulators to explore labelling changes that would support the reintroduction of the CyPass micro-stent in the future,” Dr Stephen Lane, MD, chief medical officer for Alcon, said.
The Macular Degeneration Foundation of Australia will hold education sessions for the remainder of this year:
- Brisbane, Qld: 13 October, Geebung RSL Club.
- Brisbane, Qld: 15 October, Queensland Eye Institute.
- Maroochydore, Qld: 16 October, Maroochydore RSL Club.
- Noosa, Qld: 17 October, Villa Noosa.
- Hobart, Tas: 3 November, Grand Chancellor Hotel.
- Newcastle, NSW: 12 November, Belmont 16s.
- Maitland,NSW: 13 November, Maitland Leagues Club.
Bookings: 1800 111 709.
Wearing of the white
I notice in some overseas ‘optical’ publications a sudden abundance of images of smiling practitioners wearing white coats, accompanying learned reports aimed at the faithful.
In days of yore, as a matter of course, they were worn by students in optometry courses, preparing them for when they graduated and took on the wearing of white as the done thing.
Apparently, it followed on from what medical students and practitioners did.
Today, the acres of white have largely been abandoned – by medicos and optos. Sometimes a suit, but usually smart casual for both ladies and gents.
Much more comfortable and just as professional looking.
Protecting the ‘independents’
It’s always interesting to watch the shenanigans of the self-styled protectors of ‘independent’ optometry practices in the face of fierce (and successful) competition from what they insist on calling “optical chains”.
The nonsense comes from all manner of groups, from academia to industry associations, with suppliers who wish to curry favour to ‘independents’ blathering on about how they support them, while doing as much as they can to become suppliers to the big guys.
The two faces they show are, at times, almost staggering, deserving to be disregarded for their efforts.
Heave-ho, health minister
Question: When do you know a politician is lying? Answer: When their mouth is open.
An old comment;
Read More >
An artificial intelligence system that can recommend the correct referral decision for over 50 eye diseases as accurately as world-leading experts has been developed by researchers at London’s Moorfields Eye Hospital NHS Foundation Trust, DeepMind Health and UCL.
The breakthrough research, published online on 13 August by Nature Medicine, describes how machine-learning technology has been successfully trained on thousands of historic de-personalised eye scans to identify features of eye disease and recommend how patients should be referred for care.
The researchers said they hoped that the technology could one day transform the way professionals carry out eye examinations, allowing them to spot conditions earlier and prioritise patients with the most-serious eye diseases before irreversible damage sets in.
“The number of eye scans we’re performing is growing at a pace much faster than human experts are able to interpret them. There is a risk that this may cause delays in the diagnosis and treatment of sight-threatening diseases, which can be devastating for patients,” Dr Pearse Keane, MD, consultant ophthalmologist at Moorfields Eye Hospital NHS Foundation Trust and NIHR clinician scientist at the UCL Institute of Ophthalmology, said.
“The artificial-intelligence technology we’re developing is designed to prioritise patients who need to be seen and treated urgently by a doctor or eye-care professional.
“If we can diagnose and treat
Read More >
A 42-year-old women who was hit in the face by a shuttlecock during a game of badminton as a teen 28 years ago has had found a contact-lens lodged inside her left eye at the time.
Doctors assumed the contact lens had been dislodged and was forever but in aturn of events, they have now found the contact lens.
Ophthalmologists say it migrated to her eyelid, where it has been since she was 14; she thought the lens had simply fallen out of her eye.
Unbeknown to the woman, who from Dundee, Scotland, the lens nestled its way into her eyelid after the incident.
The lens came to light after the woman complained to her GP of swelling on her left upper eyelid, which had been drooping for around half a year
Ophthalmologists conducted a series of tests on a tender lump on her eyelid, which they assumed was just a run-of-the-mill cyst.
But surgeons at Ninewells Hospital & Medical School were discovered the lump actually contained an intact contact lens.
The team were intrigued by their discovery and published it in it a medical journal.
Writing in BMJ Case Reports, they said there have been four other reported cases of contact-lens migration because of trauma to the eye.
“This case report
Read More >
Federal health minister Greg Hunt lost his bid to become deputy leader of the federal Liberal Party on 24 August in an election held for the position after a failed coup by members of the party’s hard right.
Mr Hunt survived a reshuffle of portfolios by the prime minister on 25 August, remaining minister for health.
He was one of five MPs who had lied to parliament and declared they supported the former prime minister, Malcolm Turnbull, a day after voting against him in a spill and a day before voting against the then PM again.
All five wanted conspirator Peter Dutton, not the successful Scott Morrison.