Visioneering Technologies, Inc. (VTI) announced positive findings from an analysis of three independent retrospective studies on the use of its NaturalVue Multifocal 1 Day contact lenses (NaturalVue MF) in myopic pediatric patients.
First ... talk about this product.
As VTI’s flagship product, NaturalVue MF (etafilcon A) is an extended depth-of-focus (EDOF) contact lens for managing both myopia and presbyopia.
The company’s proprietary Neurofocus Optics design creates the EDOF, allowing for multiple focal points—unlike traditional multifocal lenses, which only have two—along the visual axis and resulting in a wider range of clear vision.
And this analysis?
Entitled, “Consistency in Outcomes- Results from Three Different Retrospective Analyses,” and presented by VTI’s Executive Director of Medical Affairs Douglas P. Benoit, OD, FAAO, at the Vision by Design in Chicago, Illinois, the new research includes data from a collective 108 pediatric patients (ages 8 to 13 years with race and ethnicity matched) who wore the NaturalVue MF for 12 and 24 months.
These 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,March 29, 2023 - April 2, 2023)
- 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;16:2145-2155.
Did the studies have control subjects included?
Yup; a total of 188 virtual control subjects from 63 randomized clinical trials (RCTs) were age- and ethnicity-matched to that of the collective 108 participants wearing NaturalVue MF.
What was the rate of myopia progression?
Out of all three studies, a majority of NaturalVue MF patients progressed ≤ 0.25D in Year 1 and Year 2; the average annual progression for each was < 0.15 D for these time points.
How about axial length?
Axial length (AL) data was only available from two studies (1 and 2).
The collective AL was observed as > 0.10 mm each year for both Year 1 and 2. VTI noted this was “approximately consistent with that expected in emmetropic children.”
Explain CARE.
The cumulative absolute reduction of axial elongation (CARE) value enables clinicians to compare with greater ease the data between studies and their respective control subjects.
In this case, the CARE value vs the age- and ethnicity-matched control subjects were significant and comparable, with 0.17 mm and 0.32 mm at Year 1 and Year 2, respectively.
Further, the data demonstrated a CARE value of 0.44 mm less axial elongation over 3 years for the NaturalVue MF patients than was anticipated for the controls.
How did this compare against other myopia treatments?
The NaturalVue MF’s CARE value favorably compared against other forms of intervention:
- Compared to soft contact lenses
- CARE value = 0.30 at 3 years
- Compared to orthokeratology (ortho-k) lenses
- CARE value = 0.44 over 7 years
And refractive error?
The average annual refractive error (RE) was 0.15 D or less at Year 1 and 2 in each study
To note, this was significantly less than investigators predicted for the control subjects.
Conclusions?
Per VTI, the analysis data suggests the use of NaturalVue MF “effectively manages eye growth and refractive error among children in diverse settings over at least 2 years of follow-up.”
Considering this is based on US-based data, is there any global clinical data?
There is!
VTI expects to report interim 1-year data from the multicenter, randomized, double-masked PROTECT trial (NCT05159765) in the next few months.
The study is evaluating the use of NaturalVue Sphere single-vision contact lenses (SVCL) or NaturalVue MF for the treatment of pediatric myopia.