A few years ago, ophthalmic surgeons like Gus Gazzard of Moorfields Eye Hospital were restricted to a few procedures for glaucoma patients needing surgical interventions. Now, a flood of minimally invasive glaucoma surgery devices into the field has changed that.
But Mr Gazzard is cautioning that, while it is “an exciting, brave new world,” there is little robust data from randomised, controlled trials to help eye health practitioners and patients understand how these new implants compare to established procedures, from continued eye drop use to other surgeries.
He highlighted to OT that: “Some of these [trials] are underway, but some companies are more willing than others.”
The situation left surgeons, and optometrists who might be approached by their patients for advice, with an incomplete understanding of the best way forward for people with glaucoma, Mr Gazzard said.
“[Optometrists] are going to be seeing these devices in the eyes of their patients, and their patients will be asking about them,” Mr Gazzard outlined.
The randomised, controlled trials to compare the new devices to the gold-standard procedures require lots of time, effort and money, he warned.
The process of a new device earning regulatory approval – one currently governed by the EU’s CE mark requirements – was a simpler process than that of a new medication, Mr Gazzard confirmed.
“If the device doesn’t cause harm, or doesn’t cause harm all that often, it’s very easy to get the device to market in the EU.”