Non-contact telemetric IOP measurement via implantable pressure sensor: results from the ARGOS-02 trial

Session Details

Session Title: Presented Poster Session: Glaucoma

Venue: Poster Village: Pod 2

First Author: : L.Choritz GERMANY

Co Author(s): :    K. Mansouri   H. Thieme                    

Abstract Details

Purpose:

To evaluate the safety and performance of a novel, implantable intraocular pressure sensor in a small population of glaucoma patients.

Setting:

Prospective, open-label, multi center, single-arm clinical investigation at 10 sites in Germany, including large surgical practices and university ophthalmology departments. Principal investigator site was the Ophthalmology Department of the University Hospital Magdeburg, Germany

Methods:

A ring-shaped, foldable intraocular pressure sensor (Eyemate, Implandata Ophthalmic Products GmbH, Germany) was implanted unilaterally into the sulcus of 22 patients with open angle glaucoma during routine cataract surgery. Safety and efficacy of the device was monitored for 12 months following implantation. Agreement between the telemetric IOP measurement and Goldman applanation tonometry (GAT) was determined during each follow-up visit. Between visits patients were telemetrically self-measuring IOP and wirelessly transmitting data to a secure database.

Results:

Implantation was successful in 22 of 23 patients. In one patient, no implantation was attempted due to early complications during cataract surgery. The most common intraoperative complications were iris prolapse and pigment dispersion due to accidental iris manipulation. There was good agreement between GAT and telemetric measurements (n=434, r²=0.65), with Eyemate measurements being on average higher than GAT (+3.2 ± 3.6 mmHg), Postoperative adverse events included three cases of anterior chamber fibrin deposition, one case of cystoid macular edema, and one case of temporary corneal decompensation. All of these conditions resolved without sequelae.

Conclusions:

The Eyemate implantable pressure sensor is safe and provides accurate IOP measurements, which have the potential to improve the management of glaucoma.

Financial Disclosure:

None