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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 (plus or minus) 2.4 months (mean (plus or minus) SD) for the 26 eyes that were treated with the Ex-PRESS X-200 device. Pre-operatively, the mean BCVA was 0.6 (plus or minus) 0.3, the mean IOP was 22.0 (plus or minus) 5.1 mmHg, and the mean number of medications per patients was 2.8 (plus or minus) 0.8. Eighteen months after surgery the mean BCVA was 0.5 (plus or minus) 0.4, the mean IOP was reduced to 12.0 (plus or minus) 3.9 mmHg, and the mean number of medications per patient was 0.6 (plus or minus) 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.
S. Roy. Swiss Federal Institute of Technology, LHTC, Station 15, Lausanne, 1015, Switzerland. sylvain.roy@epfl.ch
12.8.3 Non-perforating (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)