CCTMB #006 Beyond Self-Reporting: Rethinking Adherence Monitoring in Myopia-Control Trials

By Spyridon Bissas, NIHR Pre-doctoral Fellow at Imperial Clinical Trials Unit

If a child does not receive (or does not use) a myopia-control intervention as intended, how confidently can we interpret its effect?

Clinical trials evaluating interventions designed to slow myopia progression (commonly referred to as “myopia control”) typically involve modalities that require consistent and repeated use in everyday life, such as specialised spectacle and contact lenses, topical application of atropine, overnight wear of orthokeratology lenses, and home-based repeated low-level red-light therapy. This is particularly challenging in paediatric populations, as children may not fully understand why myopia control needs to be carried out consistently and continued over several years, particularly when the benefits are not immediately apparent. As a result, parents/guardians play an important role in supporting adherence, which may depend substantially on their understanding, supervision, and involvement.

Despite its importance, adherence is inconsistently measured and reported in myopia-control trials, and even when evaluated, it is often assessed using subjective or indirect methods, such as parent- or child-reported recall, questionnaires, treatment diaries, or estimates derived from returned medication ampoules. This has traditionally been the case for spectacle-based, contact lens-based, and pharmacological interventions, raising concerns about the reliability, accuracy, and comparability of adherence data across studies. As an example, in a 2025 Cochrane living review of 104 paediatric myopia-control studies, only 25 reported treatment-adherence data, with methods varying widely and preventing robust comparison across studies.

This is where decentralised trial elements can help. By capturing intervention exposure and relevant behaviours in children’s real-world settings, rather than relying solely on periodic clinic visits and retrospective recall.

Why does adherence need more attention in myopia control trials?

Myopia control is predominantly delivered during childhood, when intervention routines are influenced by children, parents, school, and daily activities. Depending on the intervention, adherence can mean adequate wear time, sufficient exposure to natural light by being outdoors more, correct timing and technique of eye-drop use, completed light-therapy sessions, or appropriate lens care.

In practice, adherence may be influenced by everyday circumstances. For example, adherence to myopia-control spectacle lenses, such as DIMS or HAL lenses, may be affected by activities that limit opportunities for wear, including swimming and certain sports, while adherence to natural light exposure by being outdoors might be affected by seasonal changes.

Challenges in Assessing and Reporting Adherence in Myopia-Control Trials

Despite the importance of intervention adherence, its assessment and reporting remain persistent challenges in myopia-control clinical trials. As reported in a recent Cochrane systematic review of myopia control interventions in children, there is considerable variation in the definitions and methods used to assess adherence, with many studies relying on self-reported questionnaires or diaries. While parent- and child-reported data can provide valuable insights on intervention use, recall-based methods may be susceptible to reporting and recall biases, particularly when adherence is assessed retrospectively over extended periods.

The review identified inconsistencies and gaps in reporting across a variety of interventions. For example, adherence to spectacle and contact lens interventions was predominantly assessed through parent- or child-reported wearing time, while most pharmacological studies relied on self-reported questionnaires, with only one study using electronic monitoring.

These findings highlight the potential value of incorporating objective monitoring methods alongside participant-reported data to improve the assessment of intervention adherence in myopia-control trials. The issue is not simply whether children follow instructions, but whether trials can measure how much of the intervention children receive, and how this affects the interpretation of outcomes.

 Recent Advances in Adherence Monitoring on Myopia Control Trials

Connected or automatically logged red-light therapy devices:

Home-based repeated low-level red-light (RLRL) therapy is typically prescribed as short sessions using a desktop device. In a randomised trial, adherence can be calculated from the equipment’s device log (completed sessions divided by assigned sessions). This is important, as session timestamps can provide a more granular exposure record and allow trial teams to identify missed sessions earlier.

Spectacle-mounted sensors for light exposure and near-work behaviour:

Previous myopia-control trials have evaluated behavioural interventions, including increased outdoor time and modifications to near-work habits. To objectively monitor these behaviours, wearable devices attached to spectacle frames can measure eye-level light exposure and working distance in daily life.

In one study, children wore the “Clouclip” device for a week. It recorded viewing distance every five seconds and illuminance every 120 seconds, with data downloaded from a cloud platform. This offers objective, time-stamped estimates of light exposure and near-working distance (both behavioural exposures relevant to myopia research).

Smart spectacle frames:

For spectacle-based myopia-control interventions, smart frames can be an objective way to monitor wearing time and assess treatment adherence.

A 2023 prototype integrated sensors for wearing time, ambient light, viewing distance, spectral composition, and location tracking and was designed to alert users when predetermined risk thresholds were exceeded. More recently, Aston University announced a research collaboration to evaluate Blink Frames, designed to monitor spectacle-wear compliance, alongside light exposure, near work, and blink behaviour.

Among others, the list of additional elements that have been employed includes automated text-message reminders encouraging outdoor time or treatment adherence and photo- or scan-based documentation of pharmacological use.

 What Might the Future of Adherence Monitoring Look Like in Myopia-Control Trials?

Smart contact lenses are an exciting research frontier. Reviews describe experimental lenses that can sense tear biomarkers or intraocular-pressure-related changes, communicate wirelessly, and support controlled ocular drug delivery.

While there are significant challenges such as biocompatibility, long-term comfort, power supply, data security and regulation, smart contact lenses could have the potential to objectively monitor lens-wearing time and drug delivery, providing valuable information on treatment adherence and exposure.

Smart spectacle frames mentioned above are closer to practical research use, with potentially useful measurements including:

• spectacle wear time

• ambient and eye-level light exposure

• viewing distance and duration of close work

• patterns of breaks from near work &

• blink behaviour

What could be the challenges of integrating decentralised elements into myopia-control trials?

Despite their potential benefits, decentralised technologies also introduce several challenges. Collecting information about children's daily activities, treatment behaviours and environmental exposures raises concerns about data security, informed consent and the appropriate use of sensitive information. Additional challenges include ensuring the accuracy and validity of home-based measurements, addressing inequalities in digital access and managing missing data. Furthermore, reminders and continuous monitoring may themselves improve treatment adherence, which should be considered when designing trials and interpreting their findings.

Finally, it is important to remember that any decentralised elements cannot replace clinical visits, cycloplegic refraction, axial-length measurement or safety assessment. They can, however, complement the assessments by improving the monitoring of intervention adherence and participants’ experiences between visits.

Practical Takeaways

• Adherence matters: Inconsistent adherence can affect myopia-control outcomes and interpretation.

• Objective monitoring adds value: Digital tools can complement self-reported adherence data by capturing intervention use in real-world settings.

• Implementation needs care: Decentralised monitoring requires reliable measurements, appropriate data protection and continued clinical oversight

References:

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