February 1, 2024
TORONTO – At THE Myopia Meeting held here on Sunday, December 3, 2023, Amy Chow, FAAO, FBCLA, Senior Manager of Professional and Academic Affairs, presented a clinical review on behalf of CooperVision. The presentation focused on CooperVision’s MiSight 1 day contact lenses, including the technology and the seven-year MiSight 1 day clinical trial, breaking down each of the three parts of the study and the seven years of data.
Myopia as the Standard of Care
Chow started the presentation by discussing myopia in general and Canada’s decision to adopt myopia management as standard of care. She began with some audience participation, asking attendees if they experienced blurred vision and headaches as children and went to their optometrists to find a solution.
“If this happened to you, I’m sure you were probably prescribed a pair of spectacle lenses, maybe even contact lenses,” Chow said. “And somewhere down the line, we started squinting at the board again, so we would return to our optometrist, and we were prescribed even stronger spectacle lenses. Back then, myopia was considered a refractive error, something that we just needed to correct, as opposed to treat. But we now know that it’s a progressive disease, and it will only get more severe if left untreated.
“So, that’s why the World Council of Optometry and the Canadian Association of Optometrists came out with a standard of care, stating that myopia management needs to be engaged in, and we need to use evidence-based treatments.”
Breaking Down the Seven-Year Data
From there, Chow dove into CooperVision’s MiSight 1 day contact lenses seven-year clinical trial.
“MiSight 1 day is a dual-purpose lens with ActivControl technology where we have two zones for correction and two zones for treatment with 2.00D of myopic defocus. MiSight 1 day has the longest clinical trial when it comes to a soft contact lens for myopia control. It is the only FDA and Health Canada approved lens for myopia control, with seven years of data.
“We attempted to look at some of the questions when it comes to myopia control: Will MiSight 1 day work for all children? How effective is it? When should you start treatment? When should you stop treatment? And most importantly, what’s going to happen when you stop?
“The study was broken out into three parts — part one and two each consisting of three years, and a final year to study rebound. It became really apparent to the researchers halfway through part one which of the children were in the test versus the control lens, because one group was experiencing progression and the other group was leveling out.
“It became an ethical concern for the researchers to keep the kids in the control group in the control lens so in part two of the study, all the children originally in the control lens were switched into the test lens and studied for an additional three years. For the final year, in year seven, the children were all removed from the test lens and put back into the single-vision control lens to study rebound effect.”
The Results
Chow then began discussing the results and the specific answers to each question posed previously.
“We understand that MiSight 1 day works for nearly all age-appropriate children. It cuts myopia in half. While early intervention is best because the younger the child is the faster they will progress, part two of the study tells us that even if the children are entered into the lens at an older age, MiSight is still going to be effective and will work as long as the child is in the lens. Finally, the evidence indicates that there is no rebound effect. In the MiSight study, we had 90% of the children respond to MiSight 1 day, and the majority of the children that are fit in MiSight do not need a stronger prescription at their next visit to the optometrist.”
Chow then presented attendees with a hypothetical scenario of two patients to better understand the effect of MiSight 1 day on kids’ myopia.
“Hypothetically, if we look at Maria, who’s a slow progressor, versus Milo, who’s a fast progressor, you’ll see that the younger and faster progressing children will receive the maximum benefit. Take for example, Milo, who would’ve ended up at -9.00D if left untreated. In MiSight, he would end up at -5.00D. So, that’s a much better quality of life.”
From there, Chow explained that the MiSight study found that children with the fastest growing eyes are likely to benefit the most from treatment. She showed attendees a graph that compared myopia progression of the participants originally in the control over the first three years and then transitioned into MiSight for three years. The graph showed that children with the fastest growing eyes received the most benefit from the MiSight 1 day lens.
The Benefits of MiSight 1 Day
Chow then discussed the results that show that MiSight 1 day was effective at cutting myopia progression in half.
“We enrolled children between the ages of 8 and 12, and they progressed through six years of research. Between the ages of 8 and 17, we saw that myopia was slowed down by approximately 50%. While early intervention is best, in phase two of the study, we realized that even if children are started on MiSight at an older age, they’re still going to receive benefits. So, it’s never too late to start a child in MiSight. And after 10 years wear, the overall cumulative effect is predicted to be at least 2.00D or 0.87 mm of myopia control. While the children continue to wear MiSight, it shows that there’s sustained slowing of eye growth over time. As long as they continue to wear the lenses, the treatment benefits are continued.
“In the final year of study, we see that there is no rebound effect, and if there was any progression, it would’ve been at a slower, age-appropriate level. We understand that with myopia control studies, other modalities of treatment have shown rebound effect. That’s why it’s so important for us to understand that what we put our children in, is going to work, and that whatever benefits were gained over the years is not lost in the end when they’re taken out of the treatment lens.
“In summary, MiSight 1 day works for nearly all age-appropriate children. Early intervention is best, but it’s never too late to start. It works for as long as the child wears them, it cuts myopia progression in half, and there is no evidence of rebound.”
