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NEWIMPLANTGlaucoma implant offers minimallyinvasive treatmentby Dermot McGrath in Vienna

E arly results from trials of a novelintracanalicular implant (HydrusI, Ivantis Inc) show that thedevice is effective at lowering

intraocular pressure and reduces the needfor medications in patients with primaryopen angle glaucoma (POAG), according toa study presented at the XXIX Congress ofthe ESCRS.

"These early clinical results with theHydrus are very promising and the devicemay provide an interesting minimallyinvasive alternative to other surgicalmodalities intended to lower intraocularpressure," said Manfred Tetz MD, scientificdirector of the Berlin Eye Research Institute,who was the first European investigator toimplant the device.

Prof Tetz noted that the new device fitsin with the current trend towards exploringpossible surgical solutions to POAGfocusing on the trabecular meshwork andSchlemm' s canal.

Made from nitinol, a flexible nickel-titanium alloy used for vascular stents, thecrescent-shaped, non-IuminaI8.0mm longHydrus implant is a scaffold design intendedto re-establish the patient's conventionaloutflow pathway through a minirnallyinvasive, microsurgical procedure, saidProf Tetz.

"The Hydrus comes preloaded ina disposable injector system and it isimplanted using an ab-interno approachthrough a 1.0mm to 1.5mm incision intoSchlemm's canal, which minimises traumato the surrounding tissue," he said.

Since glaucoma patients often have botha blockage and a collapse of the naturaloutflow pathway, the Hydrus device relieson a twofold mechanism of action to tackleboth aspects of the problem, first creatinga relatively large opening through thetrabecular meshwork, and then dilating andscaffolding Schlernm's canal to maintain aclear outflow pathway over time.

Prof Tetz's study was carried out at sixEuropean centres on 69 patients with mild-tc-moderate glaucoma, and was intended toassess the safety and efficacy of the Hydrusimplant in two distinctly different surgicalsettings. Twenty-nine patients received theHydrus device in conjunction with cataractsurgery, while 40 patients received thedevice. alone.

Six-rnonth follow-up included

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measurements of the change in IOP andchange in glaucoma medication requiredby the patient. In the combination surgerygroup, the patients' average IOP decreasedfrom 21.1 mmHg before surgery to 15.6mmHg at the six-rnonth-follow up point.The patient's use of glaucoma medicationwas reduced from an average of 2.1 to 0.4ophthalmic eye drops per patient.

In the device-only surgery group, theaverage IOP decreased from 21.6 mmHgbefore surgery to 16.9 mmHg at follow-up,and the average medication use was reducedfrom 1.7 to 0.6 glaucoma eye drops perpatient. Furthermore, 85 per cent of patientsin the combination surgery group and 70per cent of device-only surgery patientswere free of glaucoma medication at follow-up, said Prof Tetz.

"The encouraging thing is that this effectseems to be maintained over time. We nowhave 25 per cent of patients at the one-yearfollow-up mark and this relationship hasnot changed," he said.

In terms of adverse events, Prof Tetzcited some issues with minor hyphaemaand anterior synechiae, primarily at the portof entry of the implant, but said that therehad been no problems of device migration,hypotony or corneal oedema.

Summing up, Prof Tetz said that theHydrus implant had shown its effectivenessat lowering IOP while also reducing thepatient's medication burden. He added thatfurther results and studies were needed toconfirm the effects of the procedure withand without combination cataract surgeryover a longer follow-up.

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