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InnFocus MicroShunt with MMC reduces IOP in 4-year series
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CORONADO, Calif. — In patients with primary open-angle glaucoma, the InnFocus MicroShunt reduced IOP by 55% from baseline to 11.2 mm Hg, according to a study presented here.
The tube’s dimensions and surface effects result in a predictable transscleral gradient, according to Paul F. Palmberg, MD, PhD, who presented the study at the American Glaucoma Society meeting.
Paul F. Palmberg
The 8.5-mm long shunt is made of SIBS, a non-reactive, non-erodible polystyrene. It has a 62- to 70-µm lumen and is inserted ab externo into the anterior chamber via a 3-mm needle track, which places it behind the area of upper lid rubbing where it would otherwise be vulnerable to exposure, thus negating the need for a scleral patch graft, according to Palmberg.
“Imagine a lower predictable limit of pressure, which helps prevent hypotony problems in our patients, and a fairly predictable gradient between the anterior chamber and the subconjunctival space so that we could perhaps get down to the pressures that are ideal,” Palmberg said.
Palmberg described a series of 79 eyes implanted with the device and mitomycin C and followed over 4 years. Eighty percent of eyes achieved IOP of 14 mm Hg or less from a mean baseline of 24.8 mm Hg. Mean number of glaucoma medications, which at baseline was 2.3, was reduced 61% to 0.9 medications per patient, with 62% of patients taking no glaucoma medications.
IOP of 5 mm Hg or less after postoperative day 1 occurred in 11.3% of eyes but was transient and resolved spontaneously, and there were no cases of chronic hypotony, according to the presentation. Nor were there any cases of endophthalmitis or other serious adverse events.
“So you get an immediate pressure reduction. There’s no need for suture lysis or release or adjustments after the surgery. It’s less complex surgery than tube or trab surgery. There’s less postop follow-up manipulation needed and really very good pressures,” Palmberg said, adding that an FDA randomized trial is underway to compare the MicroShunt with MMC with trabeculectomy with MMC for treatment of severe glaucoma. – by Patricia Nale, ELS
Reference:
Palmberg PF. Two-center results of a SIBS-based micro shunt at 1 to 4 years. Presented at: American Glaucoma Society annual meeting; March 2-5, 2017; Coronado, Calif.
Disclosure: Palmberg reports he is a consultant and medical monitor for the U.S. trial. InnFocus/Santen sponsored the studies.