It’s never very comfortable to get one of those eye exams, the one where they puff a jet of air into your eye, to check the pressure. But it’s quite a necessary assessment for glaucoma — or its onset.
Glaucoma is a devastating disease that harms the eye, but without manifesting early signs or symptoms – thus the need for that puff of air. It is a leading cause of blindness and vision impairment affecting around 3 million Americans, and 69 million people worldwide.
Once diagnosed, a patient can select from traditional medical approaches such as multi-drug therapy, lasers, and extensive surgical interventions.
Or they can choose a treatment called Trabectome.
Developed by NeoMedix (Tustin, California), this FDA-cleared device typically reduces intra-ocular pressure (IOP) without the aid of mechanical implants or shunts. By gently removing a portion of the patient’s clogged tissue (the trabecular meshwork), Trabectome re-establishes access to the eye’s natural drainage pathway and thus reduces the inner pressure on the eye.
The Trabectome treatment is minimally invasive and performed by glaucoma specialists as an out-patient procedure.
Joe Fieweger, director of sales for NeoMedix, told Medical Device Daily that the clogged tissue meshwork can be compared to a “clogged drain.”
He said that the therapy for clearing the drainage canals can consist of one of two things: “Either you use medication drops, which can be irritable and give the patient red eye, and can cause allergies. The other therapy is surgery, and over time ... there was something called a trabectulectomy, which – if you think of that clogged drain analogy – finds another place to drill a hole in so that the water can flow out.” That is just one type of filtering surgery.
Another type of surgery involves insertion of a shunt or implant into the eye cavity. This procedure permanently creates a drainage opening in the eye, which can lead to infections, eye irritations, and often requires numerous follow-up visits.
Offering a third alternative for this drain-clearing procedure – and avoiding the invasive cutting — is the Trabectome device.
The Trabectome handpiece resembles a dentist’s drill. It is a single-use disposable device that uses bipolar micro-electrocautery with simultaneous irrigation and aspiration. The handpiece is positioned across the anterior chamber and the tip enters the Schlemm’s canal. At the tip, the handpiece incorporates a bipolar micro-electrocautery which ablates and removes a strip of trabecular meshwork.
Simultaneous irrigation and aspiration washes away the debris and provides a stable anterior chamber while protecting the adjacent tissues.
The trabectome tip is bent to create a triangular protective footplate. This footplate provides protection from heat injury to adjacent structures, is coated with insulation material, acts as a guide inside Schlemm’s canal — a circular channel in the eye that collects aqueous humor from the anterior chamber and delivers it into the bloodstream — to protect the collector channels, and feeds tissues into the ablative bipolar electrodes as the instrument tip is advanced.
Fieweger told MDD that trabectome “is a minimally invasive tool that doctors will want to use before performing any of these filtering surgeries. It electrosugically removes the portion of that obstructive tissue that hinders the drainage and it maintains the total physiology of the eye, helps drainage return and reduces IOP pressure.
The front part of the eye is filled with a clear fluid called intraocular fluid or aqueous humor. The fluid flows out through the pupil. It is then absorbed into the bloodstream through the eye’s drainage system. This drainage system is a meshwork of drainage canals around the outer edge of the iris.
Proper drainage helps keep eye pressure at a normal level. The inner pressure of the eye depends upon the amount of fluid in the eye. If the eye’s drainage system is working properly then fluid can drain out and prevent a buildup. In most types of glaucoma, the eye’s drainage system becomes clogged so the intraocular fluid cannot drain.
As the fluid builds up, it causes pressure to build within the eye. High pressure damages the sensitive optic nerve and results in vision loss.
“We found that the success rate has been very high,” Fieweger said. “The doctors like it, and it often time reduces the amount of drug [eye drop] medications that the patient might be on. They might be on drop medications for the high pressure and be faced with maybe a filtering surgery option. If they do trabectome ... they could possibly put off filtering for sometime.”
The company says that the trabectome is currently used in leading and prestigious ophthalmic centers across the U.S. and Canada — including the Mayo Clinic (Rochester, Minnesota), Massachsetts Eye and Ear (Boston), Wilmer Eye Institute (Baltimore), New York Eye and Ear (New York), and Scripps Health Institute (San Diego).
“The Trabectome procedure provides a safer surgical alternative to the high-risk filtering procedures and tube shunt devices currently employed,” said Sameh Mosaed, MD, assistant professor of ophthalmology at University of California (Irvine).
David Marshall, MD, of The Ottawa Hospital (Ottawa, Canada) said, “Trabectome can lower pressures into the mid-teens and reduce the patient’s reliance on glaucoma medications without subjecting the eye to the risks of trabeculectomy. In addition, post-operative follow-up is easier; fewer follow-up visits are needed.”
NeoMedix is focused on developing advances in ophthalmology.