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    Glaucoma monitoring implant receives CE mark

     

    ARGOS-1 issues

    In ARGOS-1, researchers implanted the sensor in six patients with cataracts and primary open-angle glaucoma. In each patient, they placed the sensor in the ciliary sulcus through a 5.5-mm corneal incision after intracapsular lens implantation at the end of cataract surgery.

    Patients were able to use the device to measure IOP, and these measurements showed similar profiles to those of Goldmann applanation tonometry (GAT).

    However, a significant pigment dispersion occurred during the implantation in three patients, and in the first few days after implantation, four patients developed significant sterile anterior chamber inflammation. Two of these four patients showed a hypopyon of 1.5 mm.

    Neither patient showed signs of posterior segment involvement, and anterior chamber probes revealed no bacteria.

    Nevertheless, the researchers gave these patients cefuroxime, prednisolone eye drops and oral prednisolone. The inflammation resolved within 9 days after surgery in all four patients.

    Also following surgery, all patients showed mild-to-moderate pupillary distortion, with two exhibiting transillumination of the peripheral iris from the intraoperative pigment dispersion.

    In five of six patients, IOP as measured by GAT was higher 6 months after surgery than at baseline, contrary to the expected IOP lowering effect of cataract surgery. But these pressures normalised by 1 year after surgery.

    “We did a redesign of the implant after the ARGOS-01 study in order to overcome the issues we have observed in [this] study,” Ostermeier said. “The implant became smaller, more flexible [and used] an injector (similar to a IOL injector) for implant insertion. We are delighted to report that all the issues seen in the ARGOS-01 study have been resolved and [no longer] observed in the ARGOS-02 study.”

    “I firmly believe that the Eyemate system will open up new horizons towards our clinical and scientific understanding of intraocular pressure and help us to advance our treatments towards individualised and better glaucoma care,” said Professor Hagen Thieme in a press release.

    The current Eyemate system version is CE marked for use with primary open-angle glaucoma patients. Implandata is also working on other versions to be used in different glaucoma situations.

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