Combined cataract-glaucoma surgery using the intracanalicular Eyepass glaucoma implant: first clinical results of a prospective pilot study.

Purpose: To study prospectively the safety and pressure-reducing efficacy of the Y-shaped Eyepass glaucoma implant (GMP Vision Solutions, Inc.).
Setting: Departments of Ophthalmology, University of Cologne, Cologne, and University of Erlangen, Erlangen, Germany.
Methods: This study comprised 12 patients with primary open-angle or exfoliative glaucoma and cataract who had phacoemulsification with endocapsular implantation of a foldable intraocular lens and intracanalicular implantation of an Eyepass glaucoma implant. The implant is a silicone microtube shunt that bypasses the trabecular meshwork and connects the lumina of Schlemm canal with the anterior chamber in combined cataract-glaucoma surgery. Perioperative complications, intraocular pressure (IOP), and pressure-reducing topical medications were monitored over a preliminary follow-up.
Results: Perforation of the trabecular meshwork during Eyepass implantation occurred in 2 eyes; the antiglaucoma procedure was converted to trabeculotomy after the shunt was explanted, and both eyes were excluded from further follow-up. In the remaining 10 eyes, the mean maximum IOP was 30.4 mm Hg +/- 7.5 (SD) (range 21 to 46 mm Hg) preoperatively, 12.0 +/- 6.1 mm Hg (range 2 to 20 mm Hg) 1 day postoperatively, 17.2 +/- 4.1 mm Hg (range 12 to 27 mm Hg) at 4 weeks, and 18.3 +/- 4.5 mm Hg (range 12 to 25 mm Hg) at the end of the preliminary follow-up. The mean number of topical medications was 3.2 +/- 0.8 preoperatively and 0.9 +/- 0.7 at the end of follow-up (mean 7.1 months). Although there were no major complications requiring surgical revision, 4 eyes had an IOP of 18 or higher at the end of follow-up.
Conclusion: Combined cataract surgery with Eyepass shunt implantation was safe and appeared to be beneficial in glaucomatous eyes with cataract not requiring a low target IOP.