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Exci-larating 8-year Results: Novel Surgical Combo Reduces IOP

The novel ELIOS® Excimer laser trabeculostomy (ELT) procedure combined with cataract surgery has shown significant results as its 8-year follow-up outcomes were released.

The key findings indicated the combination of both procedures had largely reduced intraocular pressure (IOP), lowered the need for medication and the chances of secondary surgical glaucoma intervention.

Over an 8-year period, the study showed 161 eyes of 128 patients with glaucoma or ocular hypertension and cataract which received Phaco-ELIOS experienced a significant mean IOP reduction from 19.3 mmHg at baseline to 15.4 mmHg. A substantial reduction in medication required was recorded and only 3.7% of patients required further surgeries for glaucoma while no serious intra- or postoperative events were observed.

How it Works

Using an excimer laser, the ELIOS procedure involves creating ten 210 µm ‘microchannels’ in the trabecular meshwork. The microchannels will facilitate aqueous outflow into the Schlemm’s canal which is the eyes’ natural outflow pathway. This reduces IOP1 and thus effects the preservation of the integrity, structure and function of the trabecular meshwork.

What is interesting is that the combination of ELIOS with phacoemulsification lends to an ‘implant free’ and minimally invasive glaucoma procedure, providing a rapid learning curve for ophthalmic surgeons.

“This large cohort study provides encouraging evidence that the ‘implant free’ Phaco-ELIOS procedure causes minimal trauma, appears to show lasting IOP control with no serious intra- or postoperative complications, and low rate of incisional secondary surgical intervention over a period of at least 8 years,” said Thomas W. Samuelson, MD, founding partner of Minnesota Eye Consultants and an Adjunct Professor of Ophthalmology at the University of Minnesota.

He added that, “it is encouraging for patients that the number of topical medications required to control IOP was reduced significantly up to 4 years and remained below baseline levels across the entire 8-year follow-up period.”

Developed by Elios Vision Inc. the ELIOS procedure has been approved in Europe for adults with glaucoma (with or without cataract) while in the United States, it is undergoing clinical trials under an investigational device exemption (IDE).

The Clinical Evidence

Twelve published clinical studies2 involving over 850 eyes treated with the ELIOS procedure has demonstrated a reduction in patients’ IOPs of 20-40% from baseline, a significant reduction of medication for up to 4 years while up to 81% of patients remain ‘medication free’ at 1 year,3   as well as a good safety profile.

According to Elios, these findings demonstrate a sustained reduction of IOP that is longer than any other currently available MIGS procedure.

There has been a growing preference for minimally invasive glaucoma surgeries (MIGS) for mild to moderate glaucoma cases in the past decade or so. However, despite the attractiveness of the MIGS over more invasive procedures like trabeculectomy and tube shunts, combining cataract and glaucoma surgery has yet to gain traction among surgeons.

As the ELIOS procedure reduces IOP to the mid-teens for 8 years, at least, this just-released study is putting ELIOS on the map as a procedure that ophthalmic surgeons could consider for patients with mild glaucoma uncontrolled by medications or SLT. It has been shown to reduce postoperative inflammation while avoiding intraocular implants with a favorable safety profile, with or without cataract surgery.

The consideration comes in light of the procedure’s other advantages which include reducing the burden and side effects of drops and also potentially reducing the risk of patients undergoing two separate surgical procedures which could ease the strain on current healthcare systems.

Estimates show that in 2022, about 29 million people worldwide will undergo cataract removal with around 20% also having glaucoma or ocular hypertension.4

References

  1. Riesen M, Funk J, Töteberg-Harms M. Long-term treatment success and safety of combined phacoemulsification plus excimer laser trabeculostomy: an 8-year follow-up study. Graefes Arch Clin Exp Ophthalmol. [Published online January 16, 2022]
  2. Durr GM, Töteberg-Harms M, Lewis R, Fea A, Marolo P, Ahmed IIK. Current review of Excimer laser Trabeculostomy. Eye Vis (Lond). 2020;7:24.
  3. Moreno Valladares A, Puerto Amorós N, Mendez Llatas M, Pazos López M, Ahmed IIK. Combined excimer laser trabeculostomy and phacoemulsification: one year follow-up real world data of a laser-based MIGS. Arch Soc Esp Oftalmol (Engl Ed). 2021:S0365-6691(21)00053-8.
  4. Tseng VL, Yu F, Lum F, Coleman AL. Cataract Surgery in Medicare Beneficiaries. JAMA. 2012;308(5):493–501.
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