August 15, 2023
VANCOUVER — At THE Myopia Meeting held here June 11, 2023, Jason Shen, PhD, FAAO, presented the clinical review for EssilorLuxottica, focusing on the study results of the company’s Stellest spectacle lens for slowing the progression of myopia. Specifically, he shared the three-year myopia control efficacy of the Stellest lens H.A.L.T. (Highly Aspherical Lenslet Target) technology.
The clinical trial, which began in 2018, was conducted at the Eye Hospital of Wenzhou Medical University in Wenzhou, China. Participants were between the ages of 8 and 13 years old with a refractive error between -0.75D and -4.75D and astigmatism not higher than 1.50D. Children were assigned to either the Stellest lens or a single-vision lens, which served as the control.
Recapping Two-Year Data
After providing attendees with an overview of the Stellest clinical trial, Dr. Shen then jumped into discussing the 24-month results.
“The two primary outcomes we recorded are the spherical equivalent of cycloplegic autorefraction and the axial length measures,” Dr. Shen said. “For the spherical equivalent measurements over 24 months, the control group experienced an increase in progression of 1.46D, which is comparable with observed myopic progression rates in Wenzhou, where this study was conducted. For the Stellest lenses, over two years, the progression was 0.66D, which means myopia progression reduced by 0.80D, or 55%. The difference was highly significant already after six months when compared with the control group.
“Furthermore, the results demonstrated that wearing Stellest lenses equal or more than 12 hours per day every day, which we consider as a full-time wear, increased this efficacy to 67%, or 0.99D, on average over two years.
“When we look at axial length, the Stellest lenses slowed down axial length elongation by 0.35 mm over two years, which corresponds to 51%. Both lens groups were significantly different, starting from the six-month visit. Similarly, if we look at full-time wear of the Stellest lenses, the average increases to 60% over two years, which is 0.41 mm on average.
“Another thing we looked at is the comparison between the Stellest group and the single-vision group in terms of lens adaptation and wearer time.” Dr. Shen continued. “We found that all subjects adapted to the Stellest lens within a week, with most of the children wearing the lenses for more than 13 hours a day on average.1”
Moving Forward with the Clinical Trial
From there, Dr. Shen explained how EssilorLuxottica chose to move forward with the clinical trial after the two-year mark.
“We started to see the excellent myopia control efficacy with Stellest lenses during the interim one-year analysis, and it became clear that the way the two-year clinical trial was originally designed would not answer all questions we had. So, we wanted to extend one more year, but we were faced with a question that many clinical trials are faced with, which is: With the demonstrated efficacy of Stellest lenses, is it still ethical to keep the control group of children in the single-vision spectacles?
“We decided that this wasn’t ethical, and we moved all of the participants in the control group into Stellest lenses for the third year of the trial, and then we recruited 56 new subjects to form a new control group of single-vision spectacle wearers. The new control group were matched with the previous control group at the two-year visit, and this was done to extend the progression of the main outcomes beyond two years. The new participants were between the ages of 10-15.
“At this point, we wanted to answer a few important questions about the Stellest lenses. First, are the Stellest lenses continuing to be efficacious in the third year? If they are, what would their efficacy be compared to single vision lenses? The second question we tried to answer is: With the new control group, will the Stellest lens be able to slow myopia progression in older kids?”
Dr. Shen then broke down the three-year data from the Stellest trial. “We can say the cumulative myopia progression for the control group is just beyond -2.00D in three years. The first year, this control group had myopia progression of -0.82D, the second year it was -0.64D, and the third year it was -0.56D. The progression rate becomes slower when kids get older. However, we don’t see myopia progression stabilize at an age between 10 to 15 years.”
From there, Dr. Shen compared the myopia progression of the group that wore Stellest lenses for all three years of the trial and the combined old and new control groups. The data showed a total decrease in myopia progression of more than 1D over three years, compared to the combined old and new control groups. Dr. Shen said. “This is in a myopia control range which is of great clinical significance. It was demonstrated in the literature that slowing myopia progression by 1D should reduce the likelihood of a patient developing myopic maculopathy by 40%.2”
Lastly, Dr. Shen compared the two control groups — those who had been in single-vision lenses for two years and then switched to Stellest, and the new control group who only wore the single-vision lenses for year three.
“The new control group developed myopia progression of 0.56D in the third year,” Dr. Shen said. “The former control group that switched to the Stellest lenses developed 0.33D of myopia progression in the third year, which is 0.23D less than the new control group. Similarly, Stellest lenses slowed down axial elongation by 0.14mm on average over this 12 month period, in this older age cohort.
“This shows that Stellest lenses are efficacious even in older kids. We are extremely encouraged to have such conclusive data to show that Essilor Stellest lenses demonstrate a strong myopia control effect. Given the increased risks of ocular pathologies linked to high myopia, the Essilor Stellest lens can help in slowing down myopia progression during childhood, reducing the risk of such pathologies later in life.”
References
* You can read more on the objectives, protocol, and results of this three-year follow-up study in the recent publication of the American Journal of Ophthalmology.
1 Bao J, Huang Y, Li X, Yang A, Zhou F, Wu J, Wang C, Li Y, Lim EW, Spiegel DP, Drobe B, Chen H. Spectacle Lenses With Aspherical Lenslets for Myopia Control vs Single-Vision Spectacle Lenses: A Randomized Clinical Trial. JAMA Ophthalmol. 2022 May 1;140(5):472-478. doi: 10.1001/jamaophthalmol.2022.0401. PMID: 35357402; PMCID: PMC8972151.
2 Bullimore MA, Brennan NA. Myopia Control: Why Each Diopter Matters. Optom Vis Sci. 2019 Jun;96(6):463-465. doi: 10.1097/OPX.0000000000001367. PMID: 31116165.
