MIGS, Cataract Surgery, or Both? An Analysis of Clinical Trial Data to Compare Efficacy and Outcomes on Glaucoma Patients

Background: Glaucoma is the leading cause of irreversible blindness around the world and is characterized as a group of irreversible optic neuropathies with multiple risk factors such as age, race/ethnicity, sex, and intraocular pressure (IOP), amongst many others that play a role in disease etiology. However, IOP is the only modifiable risk factor, with higher IOP often causing increased damage to the optic nerve, resulting in the vast majority of medical and surgical treatments aiming to reduce IOP. There are a number of interventions available to treat glaucoma including micro-invasive glaucoma surgery (MIGS), whose usage has drastically increased due to its safety and efficacy. Studies also highlight the IOP-reducing effect of cataract surgery, which is the most common procedure performed globally. However, other, more targeted therapies and surgeries have been shown to have a more significant effect on IOP reduction. The objective of this study is to compare the IOP and medication reduction between cataract surgery (CS), MIGS, and MIGS and cataract surgery (MACS) clinical trials. Methods: This analysis consisted of publicly available data on CS, MIGS, and MACS clinical trials from 2005 to 2017 using ClinicalTrials.gov. Data reporting and synthesis adhered to PRISMA guidelines. MIGS interventions studied in this analysis include iStent®, CyPass® Micro-Stent, Ex-PRESS®, Hydrus®, PRESERFLO™ MicroShunt, and XEN® Gel Stent. The main variables of interest are the mean IOP and mean number of glaucoma medications used. The primary outcomes were the baseline, post-procedure, and reduction in IOP and glaucoma medication use. Cohorts were further subdivided by the follow-up period (6, 12, and 24 months), as well as their medicated or unmedicated status for pre-op IOP measurement. PROSPERO CRD42025102892. Results: A total of 21 trials were included in this review, comprising 3330 clinical trial participants: 7 CS trials (N = 570), 13 MIGS trials (N = 1577), and 9 MACS trials (N = 1183). All interventions studied resulted in a decrease in both the IOP and medication usage with varying degrees. At 12 months, the wash-out baseline IOP reduction (mmHg) was 6.9 (27.5%) for CS, 8.8 (34.0%) for MIGS, and 8.2 (32.6%) for MACS. The medication reduction was 0.8 (56.1%) following CS, 1.0 (39.5%) for MIGS, and 1.3 (86.4%) for MACS. At 24 months, the wash-out baseline IOP reduction was 6.3 (25.1%) for CS, 8.4 (33.1%) for MIGS, and 7.6 (30.1%) for MACS. At 24 months, the medication reduction was 0.9 (58.3%) for CS, 1.5 (79.8%) for MIGS, and 1.3 (86.1%) for MACS. Conclusions: The results indicate that CS, MIGS, and MACS all result in a decrease in the IOP and glaucoma medications; however, MIGS and MACS outperform CS in IOP and medication reduction. Adopting MIGS and MACS for patients with ocular hypertension or mild-to-moderate glaucoma will help improve patient outcomes through reducing the IOP and medication burden. Given that glaucoma affects certain populations to a greater degree, future research analyzing racial representation is critical in ensuring the appropriate applicability of clinical trial results toward diverse populations.