Deep sclerectomy with the Ex-PRESS X-200 implant for the surgical treatment of glaucoma

Abstract

The efficacy and safety of a newly designed Ex-PRESS X-200 drainage device for the surgical treatment of glaucoma was evaluated. A clinical, prospective, monocentric, non-randomised, unmasked study on patients with medically uncontrolled glaucoma was performed. A superficial scleral flap was created. A posterior deep sclerectomy (DS) was dissected without opening the Schlemm's canal and an Ex-PRESS X-200 device was inserted under the scleral flap into the anterior chamber to drain aqueous humour into the intrascleral space. Biomicroscopy, best-corrected visual acuity (BCVA), applanation intra-ocular pressure (IOP) measurements, and fundus examination were performed before surgery, on the first day, the first week, and 1, 2, 3, 6, 12 and 18 months after surgery. The mean follow-up was 18.6 ± 2.4 months (mean ± SD) for the 26 eyes that were treated with the Ex-PRESS X-200 device. Pre-operatively, the mean BCVA was 0.6 ± 0.3, the mean IOP was 22.0 ± 5.1 mmHg, and the mean number of medications per patients was 2.8 ± 0.8. Eighteen months after surgery the mean BCVA was 0.5 ± 0.4, the mean IOP was reduced to 12.0 ± 3.9 mmHg, and the mean number of medications per patient was 0.6 ± 1.2. Eighty-five percent of patients achieved an IOP < 18 mmHg with or without medication and 69% without medication. Post-operative complications were hyphaema (15%), Seidel (15%), encysted blebs (54%) and bleb fibrosis in 8% of patients. Mitomycin C(MMC) was administered to 15 patients (58%) with needling being performed on 10 (38%) of these patients. Mid-term results of DS with the Ex-PRESS X-200 implant demonstrated its efficacy in controlling IOP with few post-operative complications in difficult eyes with an increased risk of surgery failure.