Mid-Term Evaluation of iStent Inject^® Trabecular Micro-Bypass Stent Implantation with or without Phacoemulsification: A Retrospective Study

Introduction: This study evaluated the 6-month performance and safety of micro-invasive glaucoma surgery (MIGS) with iStent inject either with or without cataract surgery.

Material and methods: Longitudinal retrospective study of 86 surgeries in 49 patients with inadequately controlled open-angle glaucoma (OAG) or ocular hypertension who underwent iStent inject trabecular micro-bypass implantation either alone (isolated group) or combined with cataract surgery (combined group). The two primary outcomes included an intraocular pressure (IOP) drop of ≥20% versus preoperative values (adequate drop) and IOP maintenance between 6 and 18 mmHg (adequate Range). For both outcomes, we determined "complete" and "qualified" success if patients did not require or did require glaucoma medications, respectively, at the end of follow-up. Safety outcomes included best-corrected visual acuity, adverse events, and secondary surgeries.

Results: In the adequate drop analysis, 30.2% achieved "complete success," and 37.2% achieved "qualified success." For adequate range, 40.7% achieved "complete success" and 39.5% achieved "qualified success." There was no difference in medication decrease (p=0.77) nor IOP reduction (p=0.46) between the isolated and combined groups. Safety was generally favorable and similar between groups, with mild transient adverse events that resulted in no sequelae.

Discussion/conclusion: iStent inject implantation either with or without cataract surgery was able to safely decrease IOP and medication requirements through 6 months after surgery.