NaturalVue: consistent outcomes across three retrospective analyses

NaturalVue Multifocal 1 day are a soft contact lens option that manages myopia through its unique catenary-curve optics – you can read more about the novel design in our article What does extended depth of focus mean in contact lens designs? New results from three different retrospective analyses indicate consistent efficacy of the NaturalVue contact lens in slowing myopia progression.^1-3 In this article, we analyze each of these studies. 

This retrospective cohort analysis by Cooper et al evaluated the myopia progression of 196 patients wearing NaturalVue contact lenses over an approximately six year period. 62% of participants were female and 38% male; age of participants involved ranged from 5 – 20 years of age at time of NaturalVue contact lens fitting and were fit at 15 different eye care practices across the US.¹ They found that:

• 95% of wearers showed a decrease in myopia progression compared to baseline prior progression.
• 79% of wearers showed a ≥70% reduction in myopia progression, with average cumulative myopia progression never exceeding -0.27 D from baseline.
• The average change in axial length in a subset of the population (n=58 over 1 year, n=32 over 2 years and n=14 over 3 years) was approximately 0.10 mm/year, cited by the authors as “similar to that expected in emmetropic children”
• 67% of users did not show any signs of myopia progression for up to 6 years.
• Comparison to an age- and ethnicity-matched virtual control group predicted that the Cumulative Absolute Reduction of axial Elongation (CARE) value over 3 years would be 0.45 mm.

The CAMP study assessed the effectiveness of an evidence-based treatment algorithm for myopia progression in a clinical setting that involved NaturalVue Multifocal lenses, other soft multifocal contact lenses, orthokeratology, atropine and combination treatment. The algorithm involved risk factor analysis, guided treatment selection, and modification of therapy if progression exceeded 0.25D or 0.10mm in any 6-month period.² Retrospective data spanning three years from 342 myopic children obtained from two myopia control clinics was obtained and analysed. 

Across the entire patient group, mean annual axial elongation values were 0.13, 0.12, and 0.09 mm at 1, 2, and 3 years, respectively, with around half of patients meeting the success criteria each year of no more than 0.10mm annual eye growth in the prior year.

A subgroup wearing NaturalVue contact lenses as a monotherapy showed the following results (VTI Data on file, Unpublished, n-value unknown):

• 95% of children fit in NaturalVue contact lenses did not require modification of therapy throughout the study. Changes were more commonly required for children undergoing atropine treatment, in concentrations of 0.01% to 0.05%.
•  71% of children wearing NaturalVue experienced ≤ 0.25 D in 1 year.
• In comparison to a virtual control group, the CARE (cumulative absolute reduction in axial elongation) value at 1 year was 0.17mm, and at 2 years was 0.32mm indicating a good myopia control effect.

In a study by Lederman et al that was presented as a poster in the 2023 American Association for Paediatric Ophthalmology and Strabismus (AAPOS) meeting, 24 patients from an ophthalmology practice wearing NaturalVue contact lenses for myopia control were followed for 3 years. Age range was 8-13 years old, with mean CSER of -3.14D. They were instructed to wear the contact lenses 10-12 hours per day, 6-7 days a week.³ Compared to an average baseline progression of -0.81D/year, they found that:

• 96% of those wearing NaturalVue contact lenses exhibited ≤ 0.25 D change at 1 year (n=24).
• All patients wearing NaturalVue exhibited ≤ 0.50 D cumulative change over 2 years (n=14).
• 75% wearing NaturalVue exhibited ≤ 0.75 D cumulative change over 3 years (n=8).

Retrospective studies are often conducted in real-world clinical or natural settings, which can enhance the external validity of the findings compared to highly controlled research settings.⁵ While they can be valuable in that sense, it is still important to note limitations. Retrospective studies rely on existing data, which may not have been collected with the specific research question in mind: this can introduce bias or confounding variables that weren't accounted for, making it difficult to establish causal relationships or draw accurate conclusions.⁴ However, what is notable in these retrospective analyses is the consistency of outcomes:

• In all three groups, the average yearly myopia progression remained below 0.25 D.^1-3
• The majority of patients in each cohort showed a progression of less than or equal to 0.25 D in both the first and second years.^1-3
• Both cohorts with axial length data (the six-year analysis and the CAMP study) reported an annual elongation of axial length that was around 0.10 mm on average.^1-2

Although this consistency lends a degree of reliability to the studies’ results, it does not replace a randomized clinical trial. The PROTECT study is a multi-centre, randomized, double-masked clinical trial currently being conducted to investigate the myopia control efficacy of the NaturalVue multifocal contact lenses.⁶ Publication of the RCT study results will strengthen the evidence base of the NaturalVue lenses as a myopia control option, and further enhance its place in the myopia control toolkit.