Others simply say that the SOLX (Boston) DeepLight Gold Micro-Shunt will help usher in an era of glaucoma surgery that will avoid complications of traditional blebs.
Whatever the case, Gold Micro-Shunt is causing a lot of chatter among ophthalmologists because of the way it releases fluid from the eye to both decrease IOP and avoid complications.
Here, ophthalmologists, including the technology's inventor, talk about the Gold Micro-Shunt and what it will offer the field in the future.
The shunt of tomorrow
SOLX has not yet received Food and Drug Administration (FDA) approval for the Gold Micro-Shunt. But it currently has received the CE Mark in Europe and is being sold there, so clinicians now are becoming more familiar with it.
There's no one more familiar with the technology than its inventor, Gabriel Simon, M.D., Ph.D., professor of biomedical engineering, Boston University.
“The bleb generates a lot of problems,” Dr. Simon said. But the Gold Micro-Shunt is a blebless technology, he said.
“The eye naturally drains fluid from inside to inside of the eye,” Dr. Simon said. “While the uveal-scleral pathway gets damaged in about in 80% of people when you are 60 years old, this shunt technique restores the pathway. Then the eye drains fluid as it used to do it.”
Specifically, the shunt is designed to communicate between the anterior chamber and suprachoroidal space, according to company officials.
“This is the most natural way to drain fluid from the eye,” Dr. Simon said, unlike the trabeculectomy, which opens a window in the wall of the eye to drain fluid from inside to outside.
“It is so difficult to control wound healing with this window,” Dr. Simon said. “It is so difficult to control the amount of fluid that gets out of the eye. It's a strange situation in which we create a bleb and the bleb is the situation that creates the complications.”
Ike. K. Ahmed, M.D., professor of ophthalmology, University of Toronto, Canada, called trabeculectomy an “almost barbaric procedure.”
Instead of “cutting a big hole into the eye,” the Gold Micro-Shunt is an attempt to tap into the suprachoroidal space for fluid-drainage purposes, he said.
But “blebless is not really a good word” to use to describe the Gold Micro-Shunt, said Alan Crandall, M.D., professor of ophthalmology, Moran Eye Center, University of Utah, Salt Lake City. “They want flow and use a low-line diffuse bleb without direct communication to the anterior chamber.”
The end result should be less endophthalmitis and inflammation, Dr. Crandall said.
“Sure it's safer,” Dr. Crandall said. “Anytime you decrease communication with the outside, there's less of a chance of complications.”
But the issue of whether it will be optimally effective has yet to be resolved, Dr. Crandall said. Getting IOP below 17 mm Hg and ideally in the 12 to 13 mm Hg range is what ophthalmologists should be looking for, he said.
“That's the pie in the sky we're looking for,” Dr. Crandall said.
Soon-to-be lasered
In the future, SOLX hopes also to use its DeepLight Titanium Sapphire Laser to customize flow for individual patients. Their intent is to laser the Gold Micro-Shunt once it is in the eye.
Already, company officials say, the laser has been used to successfully penetrate the gold shunt.
“The next step is to link these two together to have a titratable implant that doctors can use to set target IOP for each patient,” said Doug Adams, president and CEO of SOLX. In the meantime, the laser also has received the CE mark for trabeculoplasty and also awaits approval by the FDA.
Editors' note: Drs. Ahmed, Crandall, and Simon have no financial interests related to their comments.
Top benefits of the Gold Micro-Shunt • It drains fluid from inside the eye to inside the eye (instead of outside the eye), preventing complications.
• The shunt takes advantages of the way the eye drains aqueous naturally.
• Combined with the Titanium Sapphire Laser (and pending regulatory approval), it could drain a custom amount of aqueous for each individual.
