IMI - Industry Guidelines and Ethical Considerations for Myopia Control Report.

Area of Science:

• Ophthalmology
• Optometry
• Public Health

Background:

• Myopia control (MC) treatments are increasingly prevalent.
• Ethical considerations are paramount in the development and application of these therapies.

Purpose of the Study:

• To critically review and discuss guidelines and ethical considerations for myopia control (MC) treatments.
• To explore the roles and responsibilities of all stakeholders involved in MC.

Main Methods:

• A critical review of published papers and guidance documents.
• Analysis of ethical standards in MC treatment investigation, development, registration, marketing, prescription, and use.

Main Results:

• Ethical challenges arise when implementing MC treatments, especially in minors.
• Stakeholders including regulatory bodies, manufacturers, academics, and clinicians share responsibility for ensuring safety and efficacy.
• Key considerations include decision-making for MC strategy implementation in clinical trials and practice.

Conclusions:

• A shared ethical responsibility exists among all stakeholders to ensure MC treatments are safe, efficacious, and well-understood by patients.
• Recommendations and guidelines are provided for the development, funding, prescription, and advertising of MC treatments.
• Effective knowledge transfer and education are crucial for eye care practitioners and academics regarding MC treatments.