In 2024, the waiting game will pay off for glaucoma specialists who are eager to develop fluency and implement new devices into their practices
Throughout 2023, each ophthalmology meeting featured updates on the latest glaucoma devices. We spoke to Sheng Lim, MD, professor of glaucoma studies at St. Thomas' Hospital and King's College London. He commented on the wide array of glaucoma devices that are going to make waves in the next year.
“There are many new technologies that are just being introduced, or we’re waiting for a pivotal study to prove its efficacy,” he said. The European market is uniquely positioned for an onslaught of new procedures, and many physicians are anxiously waiting for data about their efficacy – or a chance to get their hands on the new tools.
“The CE [conformité européenne] approval process is more straightforward than the FDA approval process, so as European ophthalmologists, we are blessed in that we’re able to get hold of more types of glaucoma surgical devices,” he said. “But that presents a unique set of problems—which device do you choose for which patient?”
To make matters worse, Prof Lim added, many devices work on the same area, such as trabecular meshwork, further complicating the decision for physicians. In this case, the desire to try out the latest and greatest tools can have a detrimental impact, as new skills are required to successfully deploy them. “All devices have some degree of complexity, especially when you start using it for the first time. They require some degree of learning curve,” Prof Lim explained. “Ideally, we should stick to 1 or 2 devices, and perform at least 10 procedures before we’re comfortable. It’s quite difficult to achieve that fluency in surgery, before you start implanting these in patients regularly.”
“If I start with the least invasive technology, I’ll start with direct selective laser trabeculoplasty (D-SLT), a very quick SLT that can perform without a gonioscopy lens in a patient’s eyes and that takes only a few seconds to do,” Prof Lim said. The novel non-contact procedure takes mere seconds and is already in use in Europe. Prof Lim expects the procedure, performed with the Belkin Vision Direct SLT Eagle device, to become more widespread upon release of data from a pivotal randomised control trial in 2024.
“Then you have the newer treatment, femtosecond laser image-guided high-precision trabeculotomy (FLigHT), from ViaLase. This is still in the early stages of development,” Prof Lim said. He noted that there are not much data currently available about the femtosecond trabeculotomy, but hopes the device will receive CE approval next year, and that more data on the device may be a focal point of glaucoma symposia at meetings in 2024.
New applications of excimer lasers are also currently in use. “The ELIOS Vision team is planning to start a randomised control trial to look at the excimer laser trabeculotomy, to see how effective it is compared to other treatments,” Prof Lim said. Because some glaucoma treatments can be performed at the same time as cataract surgery if they are relatively simple, it can be a widely adoptable option. "Another new treatment is minimally invasive micro sclerostomy (MIMS) from Sanoculis, which has the potential to be the next new ‘gold’ standard filtering surgery," Prof Lim said. "We are looking forward to their early clinical trial data in 2024."
Ophthalmologists should also expect to see new data on long-established technologies. “There is endoscopic cyclophotocoagulation (ECP) (BVI Medical), which is one of those technologies that has actually been out for a long time, but has never had a randomised control trial,” Prof Lim said. “Our team at St. Thomas' Hospital, in cooperation with other units in the UK, just completed recruitment for the first-ever randomised control trial on ECP laser for open-angle glaucoma.” Prof Lim said he and his colleagues hope to present the first-year data by the end of 2023 or early 2024. “We’re hoping we will be able to publish [these] data toward the end of 2024,” he said.
The most significant developments in glaucoma care over the next year may have little to do with traditional filtering surgery, such as trabeculectomy, Prof Lim said. “Filtering surgery is where the big disparity between the US and Europe becomes apparent. In most of the European market, [fewer] glaucoma surgeons are performing trabeculectomy,” he explained. “The majority have moved on to the PreserFlo Ab-Externo Microshunt, which is CE approved and hasn’t received FDA approval yet.”
Although the PreserFlo Microshunt has already become popular, doctors should expect a steady flow of research results over the next year. “This device has transformed a lot of glaucoma practices in Europe, and you’re going to see more regarding the long-term data from this particular device.”
Over 2023, the PAUL Glaucoma Implant (Advanced Ophthalmic Innovations) has gained popularity throughout the world—and especially in the UK, Prof Lim said. In 2024, he expects to see additional data on the longer-term efficacy of the PAUL implant and its effect on intraocular pressure.
The last device on Prof Lim’s list is one he is already well familiar with: the MINIject from iSTAR Medical, a suprachoroidal implant. “As this device is already CE approved, you’re going to see quite a few data being published in the course of the next year. Some of them will be from my own research unit – we’re looking at the outflow changes following the MINIject implantation,” he said.
Sheng Lim, MD | E: email@example.com
Dr Lim is a consultant at St Thomas' Hospital and professor of glaucoma studies at King’s College London, UK. He is also the research lead for the ophthalmology department and the head of KCL Frost Eye Research Department at St Thomas' Hospital.