Visioneering Technologies has announced the completed three-year results of PROTECT, a prospective, double-masked, multinational randomised control trial which shows evidence across both cycloplegic refraction and axial lengths, the two key measures of myopic progression.1,2
Over three years, the study found children wearing Naturalvue Multifocal 1 Day lenses demonstrated 1.06D less myopic refraction (95% CI 0.86 to 1.25, p < 0.001) and 0.58 mm less axial elongation (95% CI −0.66 to −0.49, p < 0.001) across three years.3,4
Naturalvue is the first and only catenary power curve soft contact lens design to demonstrate >1.00 D less myopic refractive progression over three years.3,4
“The PROTECT clinical trial adds important three-year double-masked, randomised controlled evidence to what we know about NaturalVue Multifocal 1 Day,” said Ashley Tuan, Chief Medical Officer of Visioneering Technologies. “What is especially meaningful is the breadth of the findings. We see a large refractive treatment effect together with significant slowing of axial elongation to the expected level for emmetropic children of these ages and ethnicities, providing a more complete picture of NaturalVue’s performance in children with myopia.”
The PROTECT study gives… results that are both statistically and clinically significant
The study also found that 55% of children wearing wearing NaturalVue Multifocal 1 Day had axial growth within the emmetropic benchmark of the study,3,4 and 59% progressed ≤0.25 D per year on average, consistent with the threshold commonly used to define non-progressive myopia.5 Across all the age groups studied, average axial growth trends stayed within published emmetropic growth ranges.6,7
Visioneering Technologies chief operating officer Jeff Pruett said the results provide practitioners with strong evidence to support long-term myopia management decisions.
“The broader goal is managing how much myopia each child develops over time to protect their vision for tomorrow,” he said. “The PROTECT study gives eye care professionals substantial new evidence to guide that choice, with results that are both statistically and clinically significant.”
About PROTECT
PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial; NCT05159765) is a three-year, prospective, multicenter, double-masked, randomised controlled trial conducted in the United States, Canada, Hong Kong, and Singapore. A total of 145 children aged seven up to 13 years, with cycloplegic spherical equivalent refraction (CSER) of −0.75 D to −5.00 D and astigmatism of ≤ 1.00 DC, were randomised 2:1 to NaturalVue Multifocal 1 Day (NVMF) or single-vision contact lenses (SVCL). As planned, the SVCL group crossed over to NVMF at 24 months, so 36-month NVMF outcomes were compared with modeled control data.† Of the children enrolled, 126 completed the 36-month study. Outcomes were adjusted for age, sex, ethnicity, country, study site, and baseline value.**
The three-year PROTECT results provide clinical evidence on both key measures of myopia progression: cycloplegic spherical equivalent (CSER), measured by autorefraction, and axial length, measured by optical biometry (e.g., IOLMaster, Carl Zeiss Meditec).
References
- Walline JJ, Robboy MW, Hilmantel G, et al. Food and Drug Administration, American Academy of Ophthalmology, American Academy of Optometry, American Association for Pediatric Ophthalmology and Strabismus, American Optometric Association, American Society of Cataract and Refractive Surgery, and Contact Lens Association of Ophthalmologists Co-Sponsored Workshop: Controlling the Progression of Myopia: Contact Lenses and Future Medical Devices. Eye Contact Lens. 2018;44(4):205–211. doi:10.1097/ICL.0000000000000511.
- Wolffsohn JS, Kollbaum PS, Berntsen DA, et al. IMI – Clinical myopia control trials and instrumentation report. Invest Ophthalmol Vis Sci. 2019;60(3):M132–M160. doi:10.1167/iovs.18-25955.
- Data on file. PROTECT 3-Year results, 2026. Data adjusted for key variables, including age, sex, ethnicity, country, study site, and baseline value. Per-protocol cohort, baseline age 7–<13 years, −0.75 D to −5.00 D, n = 102 (p < 0.001). All data vs. virtual control group. 36-month single-vision contact lens control values were derived from several complementary analyses, including SVCL projections (24-month SVCL patient data projected to 36 months) and a DyNaSynth™ virtual control matched to the SVCL group’s baseline characteristics. The modeled control trajectories showed a high degree of concordance with published virtual control models.
- Tuan KA, Novak S, Chan J, Dillehay SM; PROTECT Study Group. PROTECT completed 3-year study results: A catenary-curve multifocal contact lens reduces pediatric myopia progression and mitigates common risk factors. Poster presented at: American Academy of Optometry Annual Meeting; September 30–October 3, 2026; Anaheim, California.
- Chen J, Liu S, Zhu Z, et al. Axial length changes in progressive and non-progressive myopic children in China. Graefes Arch Clin Exp Ophthalmol. 2023;261(5):1493–1501. doi:10.1007/s00417-022-05901-5.
- Naduvilath T, He X, Saunders K, et al. Age, gender and regional/ethnic variations in emmetropic axial growth rate. Ophthalmic Physiol Opt. 2025;45(6):1485–1495. doi:10.1111/opo.13545.
- Zadnik K, Mutti DO, Moeschberger ML, et al. Normal eye growth in emmetropic schoolchildren. Optom Vis Sci. 2004;81(11):819–828. doi:10.1097/01.opx.0000145028.53923.67.
