The Effectiveness of First-Generation iStent Microbypass Implantation Depends on Initial Intraocular Pressure: 24-Month Follow-Up-Prospective Clinical Trial.

BACKGROUND: Evaluation of efficacy of the iStent trabecular bypass implant in reducing intraocular pressure (IOP) depending on the value pretreatment IOP and number of medications used before surgery in patients with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG) and coexisting cataract. METHODS: A prospective, uncontrolled, interventional case series. 72 patients, on a mean age of 72.42 ± 9.17, were divided into two groups depending on baseline IOP: group I < 26 mmHg and group II ≥ 26 mmHg. All subjects underwent ab interno implantation of a single iStent together with cataract surgery. Best-corrected visual acuity (BCVA), IOP, number of antiglaucoma medications, visual field, and number and type of complications were examined before and after surgery. Postoperative patients were followed up at 1, 7, and 30 days and 3, 6, 12, and 24 months. All the patients were washed out preoperatively as well as postoperatively. RESULTS: The mean observation time was 20 months. The mean preoperative IOP was 21.03 ± 1.44 mmHg in group I and reduced to mean 15.60 ± 2.12 mmHg after operation. In group II, mean IOP reduced from 26.00 ± 0.00 to 18.56 ± 1.81 (p=0.003). Mean glaucoma medications decreased from 1.35 ± 0.65 to 0.29 ± 0.52 in group I (p < 0.001) and from 2.89 ± 1.18 to 1.33 ± 1.50 in group II (p < 0.001). At 24 months, medication reduction was significantly greater in group I than group II (p=0.026). CONCLUSIONS: Combined cataract surgery with implantation of iStent seems to be an effective procedure in patients with mild-to-moderate open-angle glaucoma and cataract. In patients with baseline IOP < 26 mmHg, surgery reduced IOP and medication use significantly declined to 2 years, with greater reductions achieved versus patients with baseline IOP ≥ 26 mmHg. This trial is registered with NCT03807869.