Visioneering Announces Year 2 Findings from PROTECT Multi-center, Randomized Clinical Trial for Myopia Progression Control

Gretchyn Bailey

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Boston, Massachusetts, October 10, 2025: Visioneering Technologies, Inc., manufacturer of NaturalVue® (etafilcon A) Multifocal 1 Day Contact Lenses, presented final year 2 data from the ongoing 3-year PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) study at the American Academy of Optometry meeting in Boston. Dr. Ashley Tuan, VTI’s Chief Medical Officer, shared the data during her presentation, entitled “New Evidence Uncovered: 2-Year RCT Findings in Myopia Management, Astigmatism, and Vision Outcomes with NaturalVue”.

Year 2 Data Summary
  • Myopia progression minimization continued over 2 Years.
    • Refractive Error Treatment Effect: 0.59 D slowing of myopia*
    • Axial Length Treatment Effect: 0.22mm reduction in axial length elongation*
    • Nearly 2/3 of Patients Had Only Near Emmetropic Change in Axial Length.
  • Provide Continuous Treatment Regardless of Pupil Size.
    • Proven efficacy through year 2 across pupil sizes (2–7 mm), ideal for children active outdoors or on digital devices.
    • Larger pupils received enhanced treatment effects, strengthening myopia management.
    • Nearly 2/3 of children achieved near emmetropic change.
Note: The average indoor pupil size is 5.5 to 6.0 mm, but the range is about 2 mm to 8mm.1,2 A study from another myopia management lens design shows that if the pupil is <3.4 mm, combined with low wear time, efficacy may drop.3

  • Demonstrated Normalized Accommodative Accuracy.
    • Preserves normal accommodation responses.
    • Reduced both accommodative lead and excessive lag, bringing the accommodative response into a more typical and relaxed state.
    • Wearer’s improved accommodative state was sustained through year 2.
The myopia management results reflect the adjusted data set, equalized for key variables such as age, sex, and region.

Both 2-year adjusted treatment effect values are consistent with the 2-year values achieved by the only FDA-approved therapy for myopia progression control.

Vision, Comfort & Safety
  • Uncompromised Vision and Comfort
    • 20/20 distance and near VA maintained, comparable to spectacles.
    • Low-contrast VA equivalent to single-vision contact lenses.
    • Children reported high satisfaction**—matching single vision lenses, with no trade-offs in vision or comfort.
    • Preserved stereoacuity.
  • High Compliance & Safety
    • Children achieved comfortable wearing time of 11-12 hours per day.
    • No serious device-related adverse events occurred.
Dr. Tuan also shared an update on the performance of NaturalVue Enhanced Multifocal for astigmatism. The updated data from the clinical study ‘Evaluation of Visual Acuity with Multifocal Catenary Curve-Based Contact Lens Design in Different Degrees of Astigmatism’, conducted by University Complutense of Madrid, Spain.

Astigmatism Results
  • NaturalVue Enhanced Multifocal proved a strong degree of astigmatic compatibility.
    • Proven to correct 100% astigmatism to 3.00 D***.
    • 100% of patients achieved 20/20 or better binocular vision.
    • Maintained stereopsis and adapted to all pupil sizes.
Combined with previously published six-year retrospective data and independent studies, these findings affirm NaturalVue Multifocal’s effectiveness in controlling myopia progression.

“The two-year PROTECT results highlight what makes NaturalVue truly unique: its proprietary omnifocal design creates an extended depth of focus channel that works with the way the brain naturally processes visual information,” said Dr. Ashley Tuan, VTI’s Chief Medical Officer. “The Neurofocus Optics® technology, featuring unique extended depth of focus functionality, is the driver behind the strong effects on slowing the progression of myopia and axial elongation across pupil sizes; in addition, it has also shown that wearing NaturalVue Multifocal may help children with atypical accommodative responses move into the normal range. We’re delivering meaningful myopia progression management and preserving vision.”

Chief Executive Officer and Executive Director of VTI, Dr. Juan Carlos Aragón concluded, “With two years of randomized clinical trial results, combined with real-world studies, we now have one of the most comprehensive data sets in myopia management. NaturalVue Multifocal is emerging as a single lens that can support patients through every stage of life—from childhood myopia to digital eye strain, presbyopia, and astigmatism. That makes it uniquely positioned to meet the real-world vision needs of patients, and to support practitioners who care for them.”

To download a Fact Sheet summarizing the findings to date, click here.

About PROTECT
‘PROTECT’ (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) is a 3-year, prospective, double-masked multi-national trial evaluating the safety & effectiveness of NaturalVue® Multifocal Contact Lenses for slowing myopia progression (participating investigators in the United States, Canada, Hong Kong, and Singapore) involving 145 children.

†This information reflects the 2 Year data set (of a 3-year study). After 24 months (start of third year 3), the study protocol states that the control group will cross over to treatment. The PROTECT study is ongoing, and the data will continue to be reviewed and analyzed with additional details to be shared as available.
*Adjusted data, equalized for key variables such as age, sex, and pupil size. Data reflects Planned Subgroup ages 8-12 and power range of -0.75 to -4.00.
** Validated Patient-Reported Outcome PREP2 Survey (Pediatric Refractive Error Profile 2)
*** When following the NaturalVue fitting guide

This information may describe uses for this product, i.e., Myopia Progression Control, which have not been approved by the FDA for use in the United States. It is intended for educational purposes only. NaturalVue® Multifocal is part of an ongoing randomized clinical trial (RCT) studying its effectiveness for myopia progression control.


References
  • Connelly M, Neville K. Developmental Changes of Normal Pupil Size and Reactivity in Children. J Ped Ophthal Strab, May 2015. DOI:10.3928/01913913-20150317-11
  • Silbert et al. Pupil size and anisocoria in children measured by the plusoptiX photo screener. JAAPOS 2013;17:609-611.
  • Li Q, Fang F. Advances and challenges of soft contact lens design for myopia control. Appl. Opt. 58, 1639-1656 (2019) https://doi.org/10.1364/AO.58.001639.