- Analysis of three independent retrospective studies – 108 real-world myopes wearing NaturalVue Multifocal evaluated at 12 months and 24 months of wear.
- A majority of patients progressed ≤ 0.25D in years 1 and 2 in all three cohorts. Average annual myopia progression in each cohort was < 0.15 D in years 1 and 2.
- Average axial length change was less than 0.10 mm per year at years 1 and 2 (approximately consistent with that expected in emmetropic children).1,2
- Similar CARE value (cumulative absolute reduction in axial elongation) versus virtual control subjects during the 2-year follow-up period from both cohorts reporting axial length data.
- Year 2 myopia progression data trended closely with Year 1 values.
- Combined with the 6-year data previously published in Clinical Ophthalmology in 2022, this new analysis suggests NaturalVue Multifocal effectively manages eye growth and refractive error change among children in diverse settings over at least two years of follow up.
US-based medical device company and producer of the NaturalVue Multifocal 1 Day Contact Lenses (‘NaturalVue MF’) Visioneering Technologies, Inc presented a positive analysis of three independent retrospective studies which assessed myopic children wearing NaturalVue MF.
NaturalVue MF features the innovative Neurofocus Optics Technology, which uses an extended-depth-of-focus design to address known optical risk factors associated with the progression of myopia.
The analysis entitled, Consistency in Outcomes – Results from Three Different Retrospective Analyses, was presented by Douglas P. Benoit, OD, FAAO, executive director, Medical Affairs for VTI, at the Vision By Design meeting held in Chicago, Illinois, USA, and documents findings across 108 children wearing NaturalVue MF.
Average annual refractive error change in each study was 0.15 D or less at years 1 and 2, significantly less than predicted in age- and ethnicity-matched virtual control subjects.
Axial length data was available for two cohorts found to have increased, on average, less than 0.10 mm annually at years 1 and 2 (approximately the amount anticipated in emmetropic children).
The CARE value (cumulative absolute reduction in axial elongation) versus age- and ethnicity-matched virtual control subjects in these cohorts were significant and comparable (0.17 mm at year 1 and 0.32 mm at year 2).
The three independently conducted studies included:
- NaturalVue Monotherapy Subgroup Analysis from The CAMP study (The Clinical Algorithm for Myopia Progression) conducted by Treehouse Eyes.
- Myopia Control with Extended Depth of Focus Multifocal Contact Lenses, Carolyn R. Lederman, MD & Edward S. Harkness Eye Institute, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY (Presented as a POSTER at the 2023 American Association for Pediatric Ophthalmology and Strabismus 48th Annual Meeting, 29 March-02 April 2023)
- Subgroup Analysis from NaturalVue 6-year Retrospective data: Cooper J, O’Connor B, Aller T, et al. Reduction of myopic progression using a multifocal soft contact lens: A retrospective cohort study. Clin Ophthalmol. 2022 Jul; 16:2145-2155.
Myopia progression is caused by eyes growing abnormally in length from front to back which is termed “axial length.” Axial length change was measured for a subset of the study subjects.**
Significantly, the average axial elongation change was approximately 0.10 mm per year through 47 months of follow-up, which approximates that expected for a non-myopic child of a similar age range3 and shows that NaturalVue MF contact lenses help to reduce the anatomical cause of myopia progression.4
To be able to compare the effectiveness of NaturalVue MF to changes observed in children not wearing the lenses, an age and ethnicity matched virtual control group (N=188) developed from 63 randomized clinical trials was used.4,5
This analysis demonstrated a Cumulative Absolute Reduction of axial Elongation (Termed a ‘CARE’ value) of 0.44 mm less axial elongation over 3 years for NaturalVue MF than would be expected for age and ethnicity matched children.3 The use of the CARE value enables ECPs the ability to compare data from one study to another more easily.
The CARE value for NaturalVue MF compares very favorably to those of other myopic progression interventions such as orthokeratology lenses, with a CARE value of 0.44 over 7 years, or other soft contact lenses with a CARE value of 0.30 at 3 years.3
To provide the eye care community and potential corporate partners with additional data, VTI will soon report preview data from the 1-year interim results of their PROTECT study, the international multicentered (US, Canada, Hong Kong, and Singapore) double-blinded, randomized, and controlled study of NaturalVue MF in myopic children.
VTI’s Chief Medical Officer, Ashley Tuan, OD, PhD, commented: “Despite having vastly different demographics, with sites spread across America, the results in these three studies were remarkably similar. This demonstrates that real-world results with this unique design are consistent and repeatable.”
References
OLSM: Jones LA, Mitchell GL, Mutti DO et al. Comparison of ocular component growth curves among refractive error groups in children. Invest Ophthalmol Vis Sci. 2005; 46: 2317–2327.
SCORM: Wong HB, Machin D, Tan SB et al. Ocular component growth curves among Singaporean children with different refractive error status. Invest Ophthalmol Vis Sci. 2010; 51: 1341–1347
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. doi: 10.2147/OPTH.S370041. PMID: 35814919; PMCID: PMC9270009.
Brennan NA, Toubouti YM, Cheng X, Bullimore MA. Efficacy in myopia control. Prog Retin Eye Res. 2021;83:100923. doi:10.1016/j. preteyeres.2020.100923
Brennan NA. Why “CARE” for myopia? Review of myopia management; October 1, 2020.