Applying myopia science to practice – Q&A with Professor Debbie Jones and Professor Nicola Logan

Professor Debbie Jones is a lead clinical scientist at the Centre for Ocular Research & Education (CORE) and a clinical professor at the School of Optometry and Vision Science, at the University of Waterloo, Canada, with a special focus on myopia control and pediatric optometry. Professor Nicola Logan is the Director of Research for the Optometry and Vision Science Research Group at the School of Optometry at Aston University, Birmingham, UK. As well as conducting research into myopia control strategies, Nicola also runs the myopia clinic at the university.

We speak to both investigators in the MiSight® 1 day clinical study about the clinical research behind MiSight 1 day contact lenses and how the findings of the longest running clinical study of children wearing soft contact lenses can be translated into clinical practice.^1,2,3

Prof. Jones: The MiSight 1 day clinical study followed a classic randomized clinical trial model in part 1, with half of the children wearing dual focus, myopia control MiSight 1 day and half wearing the single vision control lens (Proclear® 1 day). A special effort was made to ensure the cohort of children were from ethnically diverse backgrounds, hence the study was conducted across four countries (UK, Portugal, Canada, and Singapore).

At the end of the first 3 years of the study, it was evident that there was a significant difference in rates of myopia progression between the two groups.¹ To ensure ethical standards and retention rates, children were given the option to continue the study for an additional 3 years (part 2), during which those who initially received Proclear 1 day lens switched to MiSight 1 day. This meant that from the beginning of year 4, there was no control group. However, this actually revealed two findings:

• Children who were 8-12 at enrolment and were assigned to the treatment group experienced 6 years of sustained, slowed eye growth.²
• MiSight 1 day treatment is effective when initiated after three years without treatment²

It's important to consider ethics in clinical trials, as they involve people, even while maintaining scientific rigor.

Prof. Jones: When performing traditional clinical trial analysis, the cohort mean is typically reported. In the case of MiSight 1 day, the cohort mean shows a reduction of 52% in axial elongation and 59% in refractive error over the first 3 years.¹ However, this approach fails to reveal if some individuals respond better to treatment than others, or if some eyes respond while others receive no treatment benefit. The most recent analysis of those individual eyes that transitioned from the control to the treatment lens showed that MiSight 1 day slowed the rate of myopia progression for 90% of eyes.²

The research also showed that most children will not need a stronger prescription by their next annual eye examination which means that children will be able to see well in between clinic visits, helping them at school and other aspects of their lives.¹

With regard to the 10% that didn't respond in the group that transitioned to MiSight 1 day in part 2, this was actually just 9 eyes, which meant that the sample size was too small to provide any meaningful analysis so we are still unable to predict who will not respond to the treatment.²

Prof. Logan: The human factor was very important to us when conducting this clinical trial. Given that myopia management involves a lifestyle change, we wanted to make sure that children were comfortable and motivated to wear the contact lenses. Since motivation also affects adherence to wearing times which is important for maximum myopia control potential, it's crucial we captured these outcomes as well.

The good news was that 90% of children in the clinical study reported that they were happy wearing their lenses and successful in handling them.¹

The study showed that children preferred wearing contact lenses, with almost 9 out of 10 expressing a strong preference for MiSight 1 day over their glasses after 3 year of wear.^1,4 This finding supports previous research indicating that children can successfully and happily wear contact lenses.^5,6,7 It has been shown that children have an improved perception relating to aspects of their lives such as participation in sports and their own appearance, when wearing contact lenses compared to spectacles. The high retention rates of 81% during the initial 3-year study and 85% during the subsequent 3-year period also serve as evidence of this.²

Parents may have concerns about young children handling contact lenses. The results showed that support was initially required from parents in some cases for application of contact lenses but all children had to be capable of removing their own lenses prior to being dispensed with lenses at the outset of the study. Interestingly, within just one month, the study found that children were able to apply and remove their contact lenses without requiring additional support.^4,5

Prof. Logan: These concerns are normal to have, but we found that children wearing MiSight 1 day in accordance with the manufacturer's instructions during the clinical trial were not at greater risk of adverse events compared with a soft contact lens wearing adult population.^8,9

It was imperative that we monitored both symptomatic and asymptomatic adverse events. Over 26,000 slit lamp observations were conducted across all study sites across parts 1 and 2 (6 years), which is equivalent to 653 years of contact lens wear. Remarkably, 99% of the slit lamp findings were classified as grade 1 or lower. There were only five cases where a slit-lamp finding greater than Grade 2 was reported.⁹ There were no instances of microbial keratitis and the one serious event recorded was not contact lens related (It was uveitis secondary to Herpes Zoster keratitis). These findings were in line with other studies looking at rates of contact lens complications among children and adults.⁸

Prof. Logan: As with any myopia control treatment, myopia control should not be stopped until there is confidence that myopia is stable.

The COMET study showed that the mean age of myopia stabilization was 15.5 years, with 48% of the children having stable myopia by 15 years of age and 77% stable by 18 years of age.¹⁰ Therefore, at 15 years of age half of those with myopia are still progressing. There is now evidence from research to show that if MiSight 1 day is stopped, the rate of axial elongation returns to the level seen in myopes of the same age wearing a single vision correction.^3,11

Considerations for stopping an intervention may include financial constraints, compliance issues, or lifestyle changes. Re-education on wear-time importance may address compliance issues. Individual assessment is crucial, as higher myopia levels benefit more from ongoing control.¹² Close monitoring and clear expectations are necessary, with a plan to resume control if myopia progression occurs.

This long-running clinical study has shown that young children can grow up into teenagers and young adults enjoying the experience of wearing MiSight 1 day which have been shown to slow down the speed at which myopia progresses.^1,2