An Examination of Demographic Involvement in Minimally Invasive Glaucoma Surgery and Cataract Surgery Clinical Trials: A Systematic Review

TL;DR

This study finds that Black individuals are underrepresented in glaucoma and cataract surgery clinical trials, despite being disproportionately affected by glaucoma.

Contribution

The study systematically evaluates demographic representation in MIGS, CS, and MACS trials using PPR metrics.

Findings

Female participants were adequately represented with a PPR of 1.00 across all trial types.

Black participants were underrepresented with an overall PPR of 0.44, significantly below the acceptable range.

Trials sponsored by medical device companies had lower Black representation compared to those by universities.

Abstract

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.

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