May 04, 2004
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EyePass glaucoma device shows promise

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SAN DIEGO, Calif. — A new glaucoma device shows efficacy on par with conventional shunts but with a better safety profile, according to a speaker here.

The EyePass device from GMP Co. consists of flexible silastic tubes, 150 µm in diameter, that facilitate drainage of aqueous fluid from the anterior chamber into Schlemm’s canal. Garry P. Condon described early clinical results with the device at a glaucoma session here at the American Society of Cataract and Refractive Surgery meeting.

Dr. Condon noted that speakers preceding him at the glaucoma session had described postoperative problems with bleb dysfunction after trabeculectomy or nonpenetrating deep sclerectomy. He said the EyePass had been developed by Reay H. Brown and Mary Lynch with the idea of finding “a better way” to address glaucoma without the difficulties of bleb maintenance.

The EyePass is a set of two ultra-flexible silastic tubes joined in a “Y” configuration. To implant the device, a scleral flap is created and Schlemm’s canal is expanded with the injection of a viscoelastic substance, The two arms of the “Y” are inserted into Schlemm’s canal, and the stem of the “Y” is inserted through the trabecular meshwork into the anterior chamber. When the anterior chamber is repressurized at the end of surgery, aqueous begins to flow from the chamber into the canal, Dr. Condon said.

Dr. Condon described results of two early clinical trials of the device. He said eight eyes implanted with the device in a phase 1 safety trial showed no significant safety issues. In a phase 2 trial of safety and efficacy in 18 patients with failed trabeculectomies, the device has shown results “on par with those of conventional tune shunts,” Dr. Condon said. Complications that have been reported with other tube shunts, including tube occlusion, choroidal detachment, erosion and hypotony, have not been seen in this series of patients, he said.