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One-year study results show reduced medication use, IOP after microstent placement
CHICAGO — At 1 year, significant reductions in IOP and medication use were observed after placement of an intracanalicular microstent device, with or without cataract surgery, according to a speaker giving first year results of a phase 3 trial.
“[Microinvasive glaucoma surgery] outcomes are often reported in conjunction with cataract surgery, making it difficult to know what pressure effect comes from the device itself,” OSN Glaucoma Section Editor Thomas W. Samuelson, MD, said at the joint meeting of the American Academy of Ophthalmology and Asia-Pacific Academy of Ophthalmology.
In the prospective, randomized, controlled multicenter study, 40 patients underwent implantation of the Hydrus microstent (Ivantis) and 20 patients underwent implantation in conjunction with cataract surgery. Patients with or without cataract had either primary open-angle glaucoma or pseudoexfoliative glaucoma with characteristic optic nerve defect, visual field or median deviation no worse than –12 dB, IOP of 26 mm Hg or less on medication, or IOP between 21 mm Hg and 32 mm Hg washed out.
Overall, there was a 69% reduction in medication use from screening to month 12, with a proportionate distribution of reduction across the classes of medications: prostaglandin analogues, beta blockers, carbonic anhydrase inhibitors and alpha agonists.
The most significant adverse effect was the loss of two lines of vision in one patient, and that was thought to be unrelated to the surgery, Samuelson said.
“The Hydrus MIGS procedure provides safe and effective IOP reduction using an ab interno surgical approach with no device migration or perforation through 12 months, and there have been no serious complications related to the procedure,” Samuelson said. “The most common postoperative complication is transient hyphema.”
Disclosure: Samuelson is an advisor and investigator for Ivantis.
