October 7, 2024
HAINAN ISLAND, China, and DALLAS, Texas — Visioneering Technologies Inc. (VTI) has presented the latest data from its PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) study at both the International Myopia Conference and Vision By Design.
Dr. Ashley Tuan, Chief Medical Officer at VTI, presented the findings at both events, highlighting results from an adjusted data analysis, complementing the previously shared unadjusted data. The poster, co-authored with Dr. Sally Dillehay, was titled, “Optical Defocus to Influence the Progression of Myopia and Eye Growth Shows Dosage-Dependency in Children,” also explored the treatment effect based on pupil size.
After equalizing other variables that also impact myopia progression (age, sex, site, and pupil size), the adjusted outcome value could better represent the true effect of the treatment. The analysis revealed outstanding outcomes for NaturalVue Multifocal, with an adjusted 89% (0.48D) reduction in refractive error progression vs. control, compared to 71% (0.41D) in the unadjusted analysis. Axial elongation showed a reduction of 0.17 mm (58%) vs. control, consistent with the 61% (0.17 mm) from unadjusted data. The adjusted analysis controls for external factors that may affect myopic progression, offering a more precise understanding of the treatment’s impact.
Children in the study experienced positive treatment effects with NaturalVue Multifocal, regardless of their pupil sizes. However, the larger the pupil size, the greater the observed treatment effect. For refractive error, this reduction reflects ≤ 0.25D myopic progression — that is considered clinically insignificant. Adjusted mean myopia magnitude was not different from baseline. With axial length the change is representative of near emmetropes. The study highlighted that even in children with smaller pupil sizes (those who spend considerable time outdoors), NaturalVue Multifocal provided continuous treatment, underscoring the importance of consistent wear for optimal results.
Early findings from the one-year data align with predictions for longer-term outcomes, with three-year data expected to reinforce these results. The ongoing PROTECT trial will continue to analyze and share data as it becomes available. Combined with previously published six-year data and analyses from three independent studies, these findings support the continued study of NaturalVue Multifocal’s effectiveness in slowing myopia progression across diverse patient populations and clinical settings.
“Regardless of pupil size, all children in the study experienced a meaningful treatment effect with NaturalVue Multifocal,” Dr. Tuan said. “These results further affirm our belief in the power of NaturalVue Multifocal to effectively manage myopia in children.”
“The comprehensive data set from the PROTECT study solidifies NaturalVue as a key tool for eye care practitioners managing myopia,” said Dr. Juan Carlos Aragón, CEO and Executive Director of VTI. “The robust results provide assurance to both practitioners and parents that NaturalVue offers excellent vision correction while helping to manage myopia.”
VTI plans to release two-year and three-year data as it becomes available, offering further insights into the long-term efficacy of NaturalVue Multifocal lenses for myopia control.
To download a Fact Sheet summarizing the findings to date, click here.