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New model of mini glaucoma shunt significantly lowers IOP
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WASHINGTON — A new mini glaucoma shunt introduced here significantly reduced IOP and medication use, and it appears to be well-tolerated by patients, a study of the device found.
The Ex-PRESS mini glaucoma shunt P50 model (Optonol) was introduced at the American Glaucoma Society meeting. It will be officially launched at the American Society of Cataract and Refractive Surgery meeting in Chicago next month, according to company officials.
The device joins the company's Ex-PRESS mini glaucoma model and has improved precision and reproducibility, with preloading for direct implantation, according to literature from Optonol.
The device was evaluated in a study presented by Steven R. Sarkisian, MD, and colleagues in a poster. The investigators conducted a retrospective, nonrandomized study of 39 patients with uncontrolled primary open-angle glaucoma or refractory glaucoma. In all cases, surgeons implanted the new P50 model under a scleral flap.
Patients averaged 66 years of age, and follow-up averaged 17 weeks, with nearly half of patients reaching 6 months of follow-up.
"The Ex-PRESS shunt has been demonstrated to be safe and effective compared to trabeculectomy," the study authors said. "A new model has been developed with minor modifications. The Ex-PRESS P50 model consists of a 50 µm internal lumen size and a back plate with a vertical split to direct flow posterior."
IOP averaged 29.7 ± 12.6 mm Hg preoperatively and was reduced to 16 ± 9.4 mm Hg at 1 day and 13.2 ± 8.1 mm Hg at 1 week. IOP averaged 13.1 ± 4.5 mm Hg by 1 month and 13.7 ± 7.6 mm Hg by 3 months, according to the study.
At 6 months follow-up, IOP averaged 12.5 ± 4.7 mm Hg, Dr. Sarkisian and colleagues reported. Nearly 75% of patients were at 15 mm Hg or less either with or without medications, and about 61% were at that same IOP level without medications, they said.
Medication use also had significantly decreased, from an average 3.3 drugs preoperatively to 0.4 at follow-up, Dr. Sarkisian and colleagues said.
There were some complications, including three patients with shallow or flat anterior chambers, two bleb leaks and one hypotony, which lasted for longer than 1 week. One patient also required a vitrectomy, and two patients required needling revision procedures.