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Representational disparity of sex, race, and ethnicity in presbyopia clinical trials: a cross-sectional study

Eye volume 37, pages 3871–3873 (2023)Cite this article

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Ophthalmic randomized controlled trials (RCTs) do not enrol participant demographics in commensurate proportions to their respective disease burden. Indeed, non-Caucasian patients are consistently underrepresented in retinal and glaucoma trials [1]. Adequate enrolment of diverse groups is needed to judiciously evaluate therapies. Presbyopia, a global concern for the aging population, is expected to affect 41% of individuals over age 40 by 2030 [2]. Herein, we investigated sex, racial and ethnic disparities in presbyopia trial enrolment.

Table 1 provides descriptive and statistical summaries of demographic enrolment. Across 1471 participants (20 trials), females were overrepresented against their disease burden (71.43%; PPR = 1.53, 95%CI [1.42,1.63]), which held over most trial characteristics. Sex overrepresentation in the ophthalmic literature appears to vary with the disease of interest, with women enrolled more often into trials for new US-approved molecular entities, yet underrepresented in diabetic macular oedema trials [3, 4]. Thus, enrolment disparities within ophthalmic conditions deserve individualized study.

Table 1 Study characteristics and enrollment by sex, age, and race.
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Fig. 1: Flow diagram of study methods and clinical trial selection.

Data availability

Available upon reasonable request to the corresponding author.

References

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Funding

This work received no funding from public, commercial, nor not-for-profit sectors. FK is the recipient of the Health Professional-Investigator Award of Michael Smith Foundation for Health Research (2023–2028); Don Rix Physician Leadership Lifetime Achievement Award (2022), BC Achievement Foundation—Mitchell Award of Distinction (2022); The University of British Columbia—Distinguished Achievement Award for Equity, Diversity & Inclusion (2022), Vancouver Medical Dental & Allied Staff Association—Diversity, Equity & Inclusion Award (2022). BT is supported by the Eye Foundation of Canada Scholarship for Medical Students. These recognitions had no role in the design or conduct of this research.

Author information

Authors and Affiliations

  1. Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada

    Brendan K. Tao

  2. Department of Ophthalmology, University of Manitoba, Winnipeg, MB, Canada

    Amir R. Vosoughi & Guillermo Rocha

  3. Department of Ophthalmology & Visual Sciences, Faculty of Medicine, Dalhousie University, Halifax, NS, Canada

    Bonnie He

  4. Department of Ophthalmology and Visual Sciences, Faculty of Medicine, The University of British Columbia, Vancouver, BC, Canada

    Jennifer Ling

  5. Faculty of Science, The University of British Columbia, Vancouver, BC, Canada

    Manvis Xia

  6. Department of Ophthalmology & Vision Sciences, University of Toronto, Toronto, ON, Canada

    Edsel Ing

  7. Department of Ophthalmology & Visual Sciences, University of Alberta, Edmonton, AB, Canada

    Edsel Ing

  8. Department of Radiology, Vancouver General Hospital, The University of British Columbia, Vancouver, BC, Canada

    Faisal Khosa

Authors
  1. Brendan K. Tao
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  2. Amir R. Vosoughi
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  3. Bonnie He
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  4. Jennifer Ling
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  5. Manvis Xia
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  6. Guillermo Rocha
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  7. Edsel Ing
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  8. Faisal Khosa
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Contributions

Study conception and design: BKT, ARV, MX, GR, EI, FK. Data collection: BKT, ARV, MX. Analysis and interpretation: BKT, ARV, BH, JL, MX, GR, EI, FK. Obtained direct project funding: N/A. Overall responsibility: BKT, ARV, GR, EI, FK.

Corresponding author

Correspondence to Faisal Khosa.

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The authors declare no competing interests.

Ethics approval

Under article 2.4 of the Tri-Council Policy Statement, this study was exempt from institutional review board approval since all data was gathered from published primary research and publicly available registries. Study results will not identify any individual nor generate new forms of identifiable information.

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Tao, B.K., Vosoughi, A.R., He, B. et al. Representational disparity of sex, race, and ethnicity in presbyopia clinical trials: a cross-sectional study. Eye 37, 3871–3873 (2023). https://doi.org/10.1038/s41433-023-02621-w

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  • DOI: https://doi.org/10.1038/s41433-023-02621-w

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