| Description: |
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, ... |