How does NaturalVue Multifocal 1 Day perform long-term for myopia?

Paper title: Reduction of Myopic Progression Using a Multifocal Soft Contact Lens: A Retrospective Cohort Study

Authors: Jeffrey Cooper (1,2), Brett O'Connor (3), Thomas Aller (4,5), Sally M Dillehay (6), Katherine Weibel (7), Douglas Benoit (8)

1. Cooper Eye Care, New York, NY, USA
2. State University of New York College of Optometry, New York, NY, USA
3. MyEyeDr - Mandarin, Jacksonville, FL, USA;
4. Thomas Aller, Optometrist, Inc., San Bruno, CA, USA
5. University of California, Berkeley School of Optometry, Berkeley, CA, US
6. ClintrialSolutions, LLC, Roswell, GA, USA
7. The Ohio State University College of Medicine, Department of Ophthalmology, Columbus, OH, USA
8. Visioneering Technologies, Inc., Alpharetta, GA, USA

Date: July 2022

Reference:  Cooper J, O'Connor B, Aller T, Dillehay SM, Weibel K, Benoit D. Reduction of Myopic Progression Using a Multifocal Soft Contact Lens: A Retrospective Cohort Study. Clin Ophthalmol. 2022 Jul 4; 16:2145-2155.

[Link to open access paper]

NaturalVue Multifocal 1 Day (NVMF) is a centre-distance, extended depth of focus design for patients with myopia and presbyopia. For children with progressive myopia, a previous pilot study¹ found a reduction in myopia progression for 81% of 32 children who wore NVMF contact lenses for between 6 and 25 months, compared to their prior progression.

This retrospective study aimed to investigate the reduction in myopia progression for a larger cohort of children and young adults wearing NVMF over a longer time period.

• Data from 196 participants who attended 15 clinical practices in the United States over a 6yr period (December 2014 to December 2020) was analysed. All of them had shown -0.50D or more myopia progression prior to being fit with NaturalVue and had not previously been fit with a myopia control treatment.
• NaturalVue lenses were worn for between 6mths and 6yrs with regular 6-monthly follow-up visits.
• Refraction was performed at baseline and at each visit - some methods were cycloplegic and some were not, with the data gathered retrospectively from a clinical setting. Axial length was measured where instrumentation was available across the clinical settings.

Myopia progression at baseline was established by annualising the 12-mth previous progression. The ongoing progression while wearing NVMF was recorded over time.

Of the 196 original participants, 101 completed at least 2yrs of the study, 64 completed 3yrs, 15 completed at least 4yrs and 7 completed the full 6yrs.  They had an average age of 12.3yrs at fitting, and were aged between 5 and 20yrs old with initial spherical equivalent refractive errors between +0.10D and -11.60D. Prior to being fit with NaturalVue, their average annualised myopic progression was -0.98±0.78D.

When all of the available refractive data was pooled into average changes from baseline at each time point, the mean progression of the group per year was between -0.11 and -0.24D. It was reported that only 14 (7%) of lens wearers experienced an increase of myopia from baseline to their most recent follow-up examination (with a range of 6 to 72 months), with the mean being -0.25D and a maximum of -0.50D.

Not every clinical setting was able to measure axial length, and some acquired the equipment during the study period. Baseline (pre-treatment) axial length measures were only available for 8 subjects, and after 1, 2 and 3 years of NVMF wear, mean axial length data was reported as showing 0.07mm (58 subjects), 0.15mm (32 subjects) and 0.14mm (14 subjects) axial elongation per year respectively. This data is hard to put into context, though, as it is comparing means of different groups and the baseline for reporting the annual 'changes' is unclear. Repeated measures analysis of those for whom data was available across all three years was not presented.

Since this was not a randomized controlled trial (RCT) and there was no control group, the data was then sectioned in two ways to facilitate comparison with the RCT data from the treatment groups in the MiSight² and BLINK³ studies. An age-matched subgroup of 33 NVMF wearers with three-year data showed minimal refractive progression of that group. No statistical comparison was made, and no axial length data was compared as it was not available for NVMF wearers.

A second data sub-analysis took data from 33 NVMF wearing children and compared their refractive progression to that established in meta-analyses of clinical trials. The meta-analysis data was used to create a 'virtual control group' of age-matched untreated progression for comparison. Refractive progression per year appeared significantly slower with the NVMF than in 'untreated' (single vision wearing) meta-analysis data. Axial length data was presented but not for the full dataset of 33 NVMF wearing children.

A projection from the Cumulative Absolute Reduction in axial Elongation (CARE) efficacy which uses more than 63 randomised clinical trials to provide a 'virtual control group', gave an anticipated 0.95D less progression over 3yrs in children wearing NVMF contact lenses.

This was a 'real-world' study conducted within clinical settings where practitioners made judgements on the suitability of the patient to be fit with NVMF. These were based on previous progression and other clinical factors, and the refraction measures were not standardised (some cycloplegic and some not).

• While this reflects expected use and clinical discussions in practice, such as using refractive error to compare progression before and after treatment, it does not reflect how myopia control efficacy has been established in RCTs of other myopia control treatments - where a control group is used to judge the treatment efficacy and measurement techniques are consistent.⁴
• This study reported that 91% of wearers showed slower refractive myopia progression compared to their pre-fitting data. In practice, a patient and parent will be pleased to see slower myopia progression with their treatment, but some slowing is expected with age anyway.⁵
• What is clear from this data is that the mean refractive progression in the total group data was less than 0.25D annually. While it is not cycloplegic data, as for RCTs (introducing some variability),⁴ it does give a clinical indication of some level of myopia control effect.
• The expected axial length outcomes are difficult to judge from the limited dataset available.

This was not a randomized clinical trial, therefore there was no control group, examiner masking or standardized measurements. Data collection from retrospective clinical setting does impose limitations on interpreting the outcomes.

• This means that a 'percentage efficacy' as reported by RCTs of other treatments cannot be calculated for this data
• The axial length data shows promise but the numbers are small. A repeated measures analysis with a larger sample would provide more robust data on absolute axial growth per year in NVMF wearers
• The lack of standardized clinical measurements (eg. cycloplegic refraction and axial length data) is not unexpected given the setting of the data collection, but this does lend some variability to the refraction results presented.
• The participants ranged in age from 5 to 20 years at commencement of wear, which includes a much older cohort than in other multifocal and multi-zone contact lens myopia control studies.^2,3 Since myopia progression slows with age,⁵ this could have contributed to the result of minimal refractive myopia progression in the cohort each year.
• Caution should be applied in comparing these results to RCT data from other studies. A gold-standard, randomized, double-masked clinical trial called the PROTECT study is currently underway to compare the cycloplegic refraction and axial length outcomes of children wearing NVMF to a control single-vision wearing group over three years.

Title: Reduction of Myopic Progression Using a Multifocal Soft Contact Lens: A Retrospective Cohort Study

Authors: Jeffrey Cooper, Brett O'Connor, Thomas Aller, Sally M Dillehay, Katherine Weibel, Douglas Benoit

Purpose: To evaluate myopia progression over an approximately 6-year follow-up period in children and young adults wearing a commercially available, daily disposable, soft multifocal contact lens with an extended depth of focus (center distance) design.

Methods: This retrospective cohort analysis included data from 196 patients of mean (SD) age 12.3 (2.7) years (range, 5-20 years), fit with the NaturalVue Multifocal (NVMF) contact lens at 15 practices in the United States over 6 years. All patients showed at least −0.50D of myopic progression in at least one eye prior to wearing the lens. Data from the right eye were analyzed. One-way ANOVA with Tukeys post-hoc t-tests were used for statistical analysis, with a significance level set at P < 0.05.

Results: After wearing these lenses for 6-72 months, the average myopia progression slowed by approximately 0.84 D or 85% compared to baseline, which was statistically significant at all time points (P < 0.0001). Frequency distribution revealed that 91% of wearers showed a decrease in myopia progression compared to baseline, with 79% of wearers showing a ≥70% reduction in myopia progression. The average change in axial length in a subset of the population over 47 months of follow-up was approximately 0.10 mm/year. Compared with changes expected in an age- and ethnicity-matched myopic virtual control group obtained from published meta-analysis data, both myopic refractive error progression and axial elongation were significantly lower in NVMF wearers at 12, 24 and 36 months (P < 0.001). Analysis of the 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.

Conclusions: Wearers of the soft multifocal contact lens displayed significant reductions in myopia progression throughout a follow-up period of 6 years.

[Link to open access paper]