SightGlass spectacle lenses reduced axial length in children after 3 years
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SAN DIEGO — Diffusion Optics Technology spectacle lenses were safe and statistically significantly reduced axial length at 3 years in children who began treatment between ages 6 and 10 years, according to a study presented at Academy 2022.
Current myopia control solutions are rarely evaluated in myopic children as young as 6 or 7 years, according to this study by SightGlass Vision’s Deborah Laughton, MSOptom, FBCLA, PhD, and colleagues.
“The CYPRESS study was designed to study safety and efficacy of Diffusion Optics Technology spectacles in 256 myopic children 6 to 10 years old,” Laughton said in her presentation. “We conducted 12-, 24- and 36-month analyses.”
Children who passed an initial screening were randomized into one of three treatment groups and received spectacles at baseline, she said.
The test lenses were designed to slightly reduce retinal contrast using thousands of micro-dots that softly scatter light, according to a company press release.
Researchers conducted cycloplegic refraction, measured axial length, and evaluated high and low contrast sensitivity and peripheral visual acuity at 1 months, 6 months and every 6 months afterwards, Laughton said.
“We included children as young as 6 and 7 years,” she said. “We know these are the kids at high risk of progressing to high levels of myopia. There’s no FDA-approved option for these young children.”
A range of ethnicities were included, she added.
“Adverse events were very low and similar among the groups,” Laughton said. “Visual acuity was similar between the test and control groups and stable across the study, for high contrast, distance, near and low contrast measurements.
“The study met the primary endpoints, to have statistically significant reduction in axial length in test vs. control,” Laughton continued. “Spherical equivalent refraction [SER] was trending in the right direction.”
She noted that baseline age and compliance to wearing schedule influenced performance.
“Children who did not take off their glasses for near vision tasks were considered compliant,” Laughton said.
The mean change in baseline in axial length was 0.59 ± 0.04 mm in the test group and 0.72 ± 0.04 mm in the control group (P = 0.018), and the mean change from baseline in SER was –0.83 ± 0.09 D in the test group and –1.16 ± 0.09 D in the control group (P = 0.0084), according to the study.
In the subgroup of 6- and 7-year-olds (n = 48), the mean change from baseline in axial length was 0.71 ± 0.07 mm in the test group and 1.03 ± 0.07 mm in the control group, and the mean change in SER was –0.89 ± 0.17 D in the test group and –1.73 ± 0.18 D in the control group.
The difference in means from baseline for axial length and SER were statistically and clinically significant, the researchers reported.
“The Diffusion Optics Technology lenses are safe and effective,” Laughton said. “However, based on the initial 12-month performance, we expected higher efficacy levels than we observed after 3 years.”
Using extension study data, the researchers can predict what might happen after the initial 3-year period, Laughton said.
“There’s a slight flattening of the curve,” she said. “We didn’t see a reduction in the progression of myopia; it looked like the progression is speeding up at a greater rate than expected.
“So, what happened after our initial 12 months and before the extension study?” she continued. “Something happened with our control group. This period did fall during the pandemic. But if we forget about this, we can see some promising results.”
The data at the 6-month point is about half of what the researchers saw during the first 12 months of the extension study, Laughton said.
“We expect these lines to keep going for the 48-month data point,” she said. “But what happened? When we think about kids, especially in the U.S., we did see a reduction in marks and reading scores. Perhaps these kids aren’t spending as much time studying or working at near. We had a good mix of urban and rural locations. Most of our kids had access to a yard or park; perhaps they spent more time outdoors.
“I’m pleased with our control group,” Laughton said. “There’s not much myopic progression. But this has impacted us studying our treatment effect.”
She said she will present the 48-month data at the academy meeting next year.
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Laughton D, et al. Safety and efficacy of a novel spectacle lens for myopia control over three years. Presented at: Academy; Oct. 26-29, 2022; San Diego.
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