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BACKGROUND: To evaluate the 6 month efficacy and safety of the iStent(®) micro-trabecular bypass stent in patients with open-angle glaucoma. DESIGN: A prospective, uncontrolled, interventional case series. PARTICIPANTS: We report on 44 eyes with open-angle glaucoma. METHODS: All subjects underwent ab interno implantation of a single iStent together with (n=40) or without (n=4) cataract surgery. MAIN OUTCOME MEASURES: Patients were assessed at post-op week 1, months 1 and 3 and, quarterly thereafter. Data collected included visual acuity, intraocular pressure (IOP) measurement using Goldmann tonometry, number of glaucoma medications and, number and type of complications. RESULTS: The mean age of the sample was 76.8 years. At the time of enrolment into the study, the mean duration since glaucoma diagnosis was 5.3 years (SD 2.9 years). The mean visual acuity was 0.53 logMAR at baseline which improved to 0.23 at 6 months post-op. The mean baseline IOP was 21.1 mmHg and this decreased significantly to 16.7 mmHg at 6 months (p < 0.01). The mean number of drops prescribed pre-operatively was 2.3 which decreased to 0.6 at 6 months (p < 0.01). Sixty-six percent of patients were drop-free at 6 months. One patient developed an hyphaema following surgery; no other adverse events were recorded. CONCLUSIONS: The iStent proved to be a safe and effective treatment for patients with open-angle glaucoma over our 6 month follow up period. Insertion resulted in a significant decrease in intraocular pressure as well as the number of topical anti-glaucoma medications required for adequate intraocular pressure control in our cohort.
Manchester Royal Eye Hospital, Central Manchester University Hospitals NHS Foundation Trust, Oxford Road, Manchester, M13 9WL, UK.
Full article12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)