Singapore Optometric Association

IMI – Industry Guidelines and Ethical Considerations for Myopia Control Report

PURPOSE. To discuss guidelines and ethical considerations associated with the development
and prescription of treatments intended for myopia control (MC).
METHODS. Critical review of published papers and guidance documents was undertaken, with
a view to carefully considering the ethical standards associated with the investigation,
development, registration, marketing, prescription, and use of MC treatments.
RESULTS. The roles and responsibilities of regulatory bodies, manufacturers, academics, eye
care practitioners, and patients in the use of MC treatments are explored. Particular attention
is given to the ethical considerations for deciding whether to implement a MC strategy and
how to implement this within a clinical trial or practice setting. Finally, the responsibilities in
marketing, support, and education required to transfer required knowledge and skills to eye
care practitioners and academics are discussed.
CONCLUSIONS. Undertaking MC treatment in minors creates an ethical challenge for a wide
variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share
an ethical responsibility to ensure that the products used for MC are safe and efficacious and
that patients understand the benefits and potential risks of such products. This International
Myopia Institute report highlights these ethical challenges and provides stakeholders with
recommendations and guidelines in the development, financial support, prescribing, and
advertising of such treatments.