OPEN-ANGLE GLAUCOMA

[caption id='attachment_4464' align='alignright' width='200'] Marco Nardi MD[/caption]

European trials of the CyPass Micro- Stent indicate that the device is a safe and effective treatment for open-angle glaucoma in newlydiagnosed, medication-naive patients, according to a study presented at the XXX Congress of the ESCRS. “Our own clinical experience and the results from the early trials show that the CyPass (Transcend Medical) has an excellent safety profile and works extremely well at reducing both IOP and the number of medications necessary to control IOP. The implant enhances the aqueous outflow through the supraciliary space and avoids many of the complications associated with conventional surgical glaucoma procedures such as trabeculectomy or shunts for the treatment of OAG,†Marco Nardi MD told delegates.

Dr Nardi, University of Pisa, Italy, described the CyPass as a biocompatible, non-biodegradable polyimide microimplantable device about 6.35mm in length and with an outer diameter of 500 microns. The device has a small lumen of 300 microns that is designed to improve uveoscleral outflow by providing access and drainage of the aqueous from the anterior chamber to the suprachoroidal space. The implant is inserted with a special inserter that enables it to be easily placed into the suprachoroidal space. “This is minimally invasive surgery because the technique uses a scleral tunnel through a 1.5mm clear corneal incision and leaves the conjunctiva, sclera and trabecular meshwork intact. It delivers controlled cyclodialysis after being implanted in the supraciliary space with direct outflow from the anterior chamber to the suprachoroidal space,†he said.

[caption id='attachment_4465' align='aligncenter' width='600'] 1. Positioning the CyPass with the special inserter is easy. Once the device is in place the inserter is retracted. 2. When the CyPass is positioned it allows free flow from anterior chamber to suprachoroideal space[/caption]

Implanting the device is very straightforward and entails no learning curve for less experienced glaucoma surgeons, said Dr Nardi. Dr Nardi presented six-month followup data from a prospective, interventional series of 22 eyes of recently diagnosed, medication-naive patients with open-angle glaucoma. Ten of the eyes underwent a combination of CyPass implantation and phacoemulsification for cataract removal, while the remaining 10 eyes received CyPass without phaco. The average patient age was 72 years with a mean baseline IOP of 26.5 mmHg, with 22.7 per cent of patients recording a baseline IOP greater than 30 mmHg. No serious intraoperative or postoperative adverse events such as retinal detachment, choroidal detachment or persistent hypotony were reported.

[caption id='attachment_4466' align='alignright' width='300'] Gonioscopic appearance of a well-positioned CyPass[/caption]

The results in terms of IOP reduction were very impressive, said Dr Nardi, with the mean IOP decreasing by about 42 per cent at three months and 39 per cent at six months postoperatively. Only about 30 per cent of patients required a single topical glaucoma medication to fully control their IOP. The remaining patients were medication free with well-controlled IOP at the six-month follow-up point. Dr Nardi highlighted a case presentation of one patient with recently diagnosed open-angle glaucoma who had the CyPass implanted without phacoemulsification.

“This patient started with a baseline IOP of 30 mmHg, which reduced to 10 mmHg at one and three months, 13 mmHg at six months and 16 mmHg after one year. And this impressive result was achieved without any glaucoma medicine,†he said. Dr Nardi added that the device can easily be combined with phacoemulsification. As a primary treatment its safety profile is consistent with a minimally invasive intervention, and the majority of patients remain medication free six months after implantation of the device. It should be considered as a primary treatment when performing phacoemulsification for cataract, or when the physician anticipates patient compliance difficulties or issues with lack of access to glaucoma medication for the patient, he concluded.