Background: Glaucoma is the leading cause of global irreversible blindness, and it disproportionately affects people of African descent, in addition to having slightly higher prevalence rates in females. Glaucoma is a group of diseases that are characterized by progressive and irreversible damage to the optic nerve, leading to eventual blindness without proper treatment. There are a number of interventions available to treat glaucoma, including MIGS, of which usage has drastically increased due to its safety and efficacy. However, with minority populations, such as people of African descent, having the highest disease burden, it remains critical to evaluate the diversity of clinical trial populations that are used in the study of glaucoma treatments. The objective of this study is to compare the representation of Black and other ethnic minorities, as well as female participants, between cataract surgery (CS), minimally invasive glaucoma surgery (MIGS), and MIGS and cataract surgery (MACS) trials. Methods: This analysis consisted of publicly available data on MIGS, CS, and MACS clinical trials from 2005 to 2017, using ClinicalTrials.gov as well as prevalence data sourced from the CDC. Data reporting and synthesis adhered to PRISMA guidelines. This study focuses on sex rather than gender, as this is how data was reported on ClinicalTrials.gov. The primary outcome was the participation-to-prevalence ratio (PPR) of each clinical trial. A PPR between 0.8 and 1.2 represents adequate representation, while a PPR less than 0.8 or greater than 1.2 can signify under- or over-representation, respectively. 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 of the clinical trials included data on sex, while only 14 reported race data and 7 reported ethnicity data. The overall PPR of female participants was 1.00, with CS, MIGS, and MACS clinical trials having PPRs of 0.99, 1.00, and 1.00, respectively. On the other hand, the overall PPR of Black participants was 0.44, with CS, MIGS, and MACS clinical trials having PPRs of 0.27, 0.62, and 0.22, respectively. Further analysis demonstrated that the PPR of Black participants in trials sponsored by medical device companies and medical centers or universities was 0.41 and 1.25, respectively. The study was registered with Prospero CRD420251152586. Conclusions: Cataract surgery, MIGS, and MIGS and cataract surgery clinical trials under-represent Black individuals and appropriately represent females. Due to the disproportionate amount of Black individuals impacted by glaucoma, this lack of representation raises concerns about the applicability of the clinical trials to these populations. Understanding clinical trial disparities in the representation of minority races is a key first step toward promoting advancements in diversity and equitable healthcare. Clinical trials in the future need to make a genuine effort to include minority groups to improve the generalizability of results.

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.