Introduction: To describe the 12-month efficacy and safety of goniotomy performed using the Kahook Dual Blade (KDB) in combination with cataract surgery in eyes with medically treated open-angle glaucoma (OAG). Methods: This was a prospective, interventional case series conducted at seven centers in North America. Consecutive patients with medically treated OAG and visually significant cataract underwent phacoemulsification combined with goniotomy (PE + goniotomy) using KDB. Indications for glaucoma surgery included reduction of intraocular pressure (IOP) and reduction of IOP-lowering medications. De-identified data were collected and included pre-, intra-, and postoperative data on IOP, the use of IOP-lowering medications, and adverse events through 12 months of follow-up. Results: Among 52 eyes undergoing surgery, mean IOP was reduced from 16.8 ± 0.6 mmHg at baseline to 12.4 ± 0.3 mmHg at month 12 (P < 0.001), a 26.2% reduction. Mean IOP across time points ranged from 12.4–13.3 mmHg during follow-up. The mean number of topical IOP-lowering medications was reduced from 1.6 ± 0.2 at baseline to 0.8 ± 0.1 at month 12 (P < 0.05), a 50.0% reduction. At month 12, 57.7% of eyes had IOP reduction ≥ 20% from baseline, and 63.5% were on ≥ 1 fewer IOP-lowering medications. In subgroup analysis, 84.6% of eyes with lower mean baseline IOP were using ≥ 1 fewer medications at month 12, and 100% of eyes with higher mean baseline IOP had IOP reductions ≥ 20%. The most common postoperative adverse events were pain/irritation (n = 4, 7.7%), opacification of the posterior lens capsule (n = 2, 3.8%), and IOP spike > 10 mmHg (n = 2, 3.8%). Conclusion: PE + goniotomy using the KDB significantly lowers both IOP and dependence on IOP-lowering medications in eyes with OAG. Adverse events were not sight-threatening and typically resolved spontaneously. Funding: New World Medical, Inc.
- Cataract surgery
- Intraocular pressure
- Micro-incisional glaucoma surgery
- Micro-invasive glaucoma surgery
- Trabecular meshwork