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IMI - Clinical Myopia Control Trials and Instrumentation Report
James S Wolffsohn1, Pete S Kollbaum2, David A Berntsen3
1Ophthalmic Research Group, Aston University, Birmingham, United Kingdom.
Abstract:
The evidence-basis based on existing myopia control trials along with the supporting academic literature were reviewed; this informed recommendations on the outcomes suggested from clinical trials aimed at slowing myopia progression to show the effectiveness of treatments and the impact on patients. These outcomes were classified as primary (refractive error and/or axial length), secondary (patient reported outcomes and treatment compliance), and exploratory (peripheral refraction, accommodative changes, ocular alignment, pupil size, outdoor activity/lighting levels, anterior and posterior segment imaging, and tissue biomechanics). The currently available instrumentation, which the literature has shown to best achieve the primary and secondary outcomes, was reviewed and critiqued. Issues relating to study design and patient selection were also identified. These findings and consensus from the International Myopia Institute members led to final recommendations to inform future instrumentation development and to guide clinical trial protocols.
Insights
This review outlines key outcomes for myopia control trials, focusing on refractive error and patient-reported data. Recommendations guide future research and treatment effectiveness studies.
Area of Science:
- Ophthalmology
- Optometry
- Clinical Research
Background:
- Myopia control trials aim to slow myopia progression and assess treatment effectiveness.
- Standardized outcome measures are crucial for evaluating myopia control interventions.
- Existing literature and trial data inform best practices in myopia management.
Purpose of the Study:
- To review and classify outcomes for myopia control clinical trials.
- To identify and critique instrumentation for measuring myopia progression.
- To provide recommendations for future trial design and instrumentation.
Main Methods:
- Systematic review of myopia control trial evidence and academic literature.
- Classification of outcomes into primary, secondary, and exploratory categories.
- Critique of current instrumentation for assessing myopia control efficacy.
Main Results:
- Primary outcomes include refractive error and axial length; secondary outcomes involve patient-reported data and compliance.
- Exploratory outcomes encompass a wide range of ocular measurements and patient factors.
- Current instrumentation is best suited for primary and secondary outcomes, with limitations noted.
Conclusions:
- Recommendations are provided for future myopia control trial protocols and instrumentation development.
- Standardized outcome selection and measurement are vital for advancing myopia control research.
- Addressing study design and patient selection issues will enhance trial validity.
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