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January 2, 2025
By Brett O’Connor, OD, FAAO
With myopia reaching epidemic proportions in countries around the world, eye care practitioners are eager for new and better technologies to manage this growing problem.1 The impressive one-year dataset from the ongoing three-Year PROTECT study (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) offers promising insights into how this unique lens design can revolutionize myopia management for patients and providers alike.
Neurofocus Optics: Efficacy at Year 1
One of the core technologies inside NaturalVue Multifocal is Neurofocus Optics Technology, a patented, highly aspheric optical design that generates up to 8.00D of relative plus power through the average child’s pupil.2-4 The seamless power transition of this design avoids the use of distinct optical zones and effectively mitigates peripheral hyperopia, which is widely recognized as a significant driver of myopia progression.
Through Year one of the PROTECT study, children between 8 and 12 years old with baseline cycloplegic spherical equivalent autorefraction between -0.75D and -4.00D, wearing NaturalVue Multifocal, have demonstrated a very robust treatment effect versus children wearing single vision lenses:
- Adjusted treatment effect5 of -0.48 D (89%) and 0.17 mm (58%)6
- Only -0.06 D of adjusted average myopia progression in subjects wearing NaturalVue Multifocal6
The strength of this planned subgroup analysis is that it incorporates covariates such as age and sex at baseline, which provides the best representation of one-year efficacy. Notably, regression analysis revealed that children with larger pupils experienced even less myopia progression, thanks to the greater peripheral myopic defocus provided. However, the lens design ensured a significant treatment effect even for those with smaller pupils — a testament to its unique lens design.
Uncompromised Vision in All Environments
The optimal lens for myopia management must balance strong efficacy with outstanding visual performance that meets or exceeds single vision correction. Through Year one of the PROTECT study, NaturalVue Multifocal has provided excellent visual acuity across a range of visual environments:
- High contrast: Distance and near visual acuity better than 20/20, on average, comparable to both baseline best-corrected vision and single vision contact lens-wearing counterparts7
- Low contrast: Distance visual acuity within one line of baseline best-corrected vision and participants wearing single vision lenses7
These results indicate NaturalVue Multifocal provides uncompromised vision for children across the full range of everyday visual environments, making this lens a versatile choice for daily activities.
Enhancing Accommodative Function
One of the most interesting findings of the PROTECT one-year dataset is NaturalVue Multifocal’s impact on accommodative lag. Children wearing both single vision contact lenses and NaturalVue Multifocal displayed approximately 1.00D of accommodative lag at baseline; however, after one year, a clear distinction became evident:
- NaturalVue Multifocal wearers experienced a decrease in lag of approximately 0.25D, resulting in a lag of accommodation of approximately 0.75D at one year.
- Single vision lens wearers experienced no change in lag of accommodation, on average
Zooming in even closer on this data, subjects wearing NaturalVue Multifocal with higher baseline accommodative lag tended to see larger decreases in lag, whereas children who demonstrated a lead of accommodation at baseline actually tended to experience relaxed accommodation, often resulting in a small accommodative lag at one year.7 These findings suggest that NaturalVue Multifocal may enhance accommodative accuracy and near vision performance — a critical benefit in the digital age, where prolonged near work and digital eye fatigue in children are commonplace.
A Win for Patient Satisfaction
The PROTECT randomized controlled trial employs the validated PREP2 questionnaire to assess patient-reported outcomes, with questions gauging satisfaction in the realms of vision, symptoms (comfort), and activities.7 At one year wearers of NaturalVue Multifocal reported an increase in satisfaction across these categories compared to baseline spectacle correction. Despite the high amount of relative plus power, no difference in satisfaction was observed between children wearing NaturalVue Multifocal versus single vision correction.7 This may be a critical advantage over zonal designs such as the one used in the BLINK study, where multifocal lens satisfaction with a +1.50 zonal contact lens design was equivalent to that with single vision correction, but inferior with the 2.50D Add design.8
A Proven Choice for Myopia Management
NaturalVue Multifocal was already known to provide excellent vision and myopia management properties from retrospective analyses involving various groups, including children with high astigmatism (up to -1.75D).9 With the PROTECT RCT, NaturalVue Multifocal now boasts robust, real-world evidence from a randomized controlled trial, validating its effectiveness over one year. For eye care practitioners seeking evidence-based interventions to address the myopia epidemic, NaturalVue Multifocal offers a reliable, patient-friendly solution that delivers measurable benefits to correct and protect children’s vision. As the myopia epidemic continues to unfold, the learnings from the PROTECT RCT one-year dataset underscore the power of NaturalVue Multifocal to slow myopia progression and enhance patient satisfaction, offering children clearer vision and a brighter future.
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Brett O’Connor, OD, FAAO, practices in Jacksonville, FL, where he splits his professional time between patient care and research and development for new myopia management technologies. He is an alumnus of Southern College of Optometry and a fellow of the American Academy of Optometry, also serving as President of the Northeast Florida Optometric Society. |
Brett O’Connor, OD, FAAO, is an optometrist in Jacksonville, FL, owner of Acuity Insights LLC. Dr. O’Connor was compensated for his time in preparing this article.
Note: This information reflects the 1-Year dataset. The PROTECT study is ongoing, and the data will continue to be reviewed and analyzed with additional details to be shared as available.
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 and is intended for educational purposes only. NaturalVue Multifocal is part of an ongoing clinical trial (RCT) that is studying its effectiveness for myopia progression control.
References
- Holden BA, Fricke TR, Wilson DA, et al. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42.
- Brown JT, Connelly M, et al. Developmental Changes of Normal Pupil Size and Reactivity in Children. J Pediatr Ophthalmol Strabismus. 2015 May-Jun;52(3):147-51.
- Silbert J, Matta N, et al. Pupil size and anisocoria in children measured by the plusoptiX photoscreener. J AAPOS. 2013 Dec;17(6):609-11.
- Tuan KA, O’Connor B, et al. Randomized Controlled Trial for Myopia Progression Control Using Catenary Power Profile Contact Lenses and Real-World Studies Comparisons. Global Specialty Lens Symposium Meeting, January 2024.
- Akerman D. Evidence-Based Myopia Care. Rev Myopia Management. 2024 Sep 3. Retrieved from reviewofmm.com/evidence-based-myopia-care.
- Tuan KA, Dillehay SMD. Optical Defocus to Influence the Progression of Myopia and Eye Growth Shows Dosage-Dependency in Children. International Myopia Conference. 2024 Sep 9. Hainan, China.
- Tuan KA, Dillehay SM. Patient Reported Outcomes in a Randomized Controlled Myopia Progression Study (PROTECT) of a Soft Multifocal Contact Lens. American Academy of Optometry. 2024 Nov 8. Indianapolis, IN.
- Dougherty BE, Jordan L, et al; Pediatric Refractive Error Profile 2 (PREP2) Validation Study. Invest Ophthalmol Vis Sci. 2021;62(8):2338.
- Walline JJ, Walker MK, et al. Effect of High Add Power, Medium Add Power, or Single-Vision Contact Lenses on Myopia Progression in Children: The BLINK Randomized Clinical Trial. JAMA. 2020;324(6):571–580.
- Cooper J, O’Connor B, et al. Reduction of Myopic Progression Using a Multifocal Soft Contact Lens: A Retrospective Cohort Study. Clin Ophthalmol. 2022 Jul 4;16:2145-2155.
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