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S. Roy, A. Bissig, J. Broquet, A. Mermoud; Deep Sclerectomy With the Ex-Press X-200 Implant for the Surgical Treatment of Refractory Glaucomas. Invest. Ophthalmol. Vis. Sci. 2007;48(13):816.
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To evaluate the efficacy and safety of a newly designed Ex-PRESS X-200 drainage device for the surgical treatment of refractory glaucoma.
This clinical, prospective, monocentric, non-randomized, unmasked study was performed on 28 eyes of 28 patients with medically uncontrolled glaucoma and/or previous failed glaucoma surgeries. Deep sclerectomy with X-200 drainage device implantation under a scleral flap was performed. Complete examinations including biomicroscopy, best corrected visual acuity (BCVA) and applanation intraocular pressure (IOP) measurements, fundus examination with a vC/D assessment, were performed before surgery, at 1 day, 1 week, and 1, 2, 3, and 6 months after surgery.
The mean age was 72 ± 16 years (mean ± SD). The mean post operative follow-up was 5.87 ± 0.81 months. The preoperative IOP was 22.6 ± 6.0 mmHg and the BCVA 0.53 ± 0.33. At 6 months the IOP was 12.0 ± 4.6 mmHg and the BCVA remained at 0.54 ± 0.35. The mean number of medication per patient went from a preoperative value of 2.9 ± 0.9 down to 0.4 ± 0.9 at 6 months postoperative, the medication being generally reintroduced at the second month. No major complications were reported. Mitomycin C treatments with needling were given to 11 patients (39.3%). The complete success (IOP ≤ 18 mmHg without medication) was 71.4%, and the qualified success (IOP ≤ 18 mmHg witht medication) was 89.3%. The complete failure (further surgery required) was 10.7%.
Short term results (6 months) demonstrate that the deep sclerectomy using the new Ex-PRESS X-200 implant significantly reduces the intraocular pressure with few complications. These preliminary results lead to the conclusion that this new and simplified deep sclerectomy technique is an easy, safe and efficient procedure to adequately control IOP in refractory glaucoma patients.
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