Race and Ethnicity Reporting and Representation in Micro-Invasive Glaucoma Surgery (MIGS) and Glaucoma Drainage Device (GDD) Clinical Trials: A Systematic Review

Author Type(s)

Student

Document Type

Abstract

Publication Date

6-2024

Journal Title

Investigative Ophthalmology & Visual Science

Abstract

Purpose : In 2020, 52.7 million individuals were impacted by Glaucoma and projections indicate a continued rise in the number of cases. The disease burden is higher in Black individuals and other racial/ethnic minorities. There are a number of surgical interventions available to combat the effects of Glaucoma, including: trabeculectomy, GDD, and MIGS. MIGS has seen a 400% increase in procedures between 2012 to 2016. However, studies have found that Black patients, compared with White patients, saw an increased risk of reoperation. Given the growing popularity of MIGS procedures, researchers need to pay particular attention to improving diversity in clinical trials

Methods : This systematic review consisted of publicly available data on MIGS and GDD clinical trials using ClinicalTrials.gov and PubMed from 1987 to 2020 that reported demographic subgroups including race/ethnicity. Microsoft Excel and Python, were used for data collection and analysis. Data reporting and synthesis adhered to PRISMA guidelines. The primary outcomes were the prevalence of each demographic subgroup according to the trial start year, study region, mean age, and study sponsor

Results : 67 clinical trials were included in this review, comprising 6,156 clinical trial participants. Overall, 69.1% were White, 16.2% were Black, 5.2% were reported as Hispanic/Latino patients, 50.9% were female, and 14.7% were individuals of other races/ethnicities. Black participation was lower in MIGS clinical trials (12.0%) and studies sponsored by U.S. medical device companies (7.5%) . A linear regression and 1-way ANOVA were performed to assess significant trends between participation by Black individuals and the independent variables.

Conclusions : The results suggest that racial and ethnic minority groups have a significantly lower participation rate in MIGS clinical trials compared with White individuals. Additionally, these trends were more prevalent in European studies and those sponsored by U.S. medical device companies. This underrepresentation raises concerns regarding the safety and effectiveness of approved surgical interventions. There is a compelling need for expanded initiatives aimed at enhancing diversity in future clinical trials. As well as an imperative to advance the quality of race and ethnicity data reporting in future studies.

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