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VTI’s Six-Year Clinical Trial Data Published in Clinical Ophthalmology

July 8, 2022

ATLANTA — Findings from Visioneering Technologies Inc.’s (VTI) six-year myopia management clinical trial were published in the Clinical Ophthalmology journal. The study reported data with 196 real-world subjects on the impact of its NaturalVue Multifocal (MF) on children with myopia. VTI’s NaturalVue MF contact lenses feature 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. 

Clinical Ophthalmology is an international, peer-reviewed journal covering all subspecialties within ophthalmology. The publication of the peer-reviewed data in this journal provides further validation of NaturalVue MF’s effectiveness in slowing or stopping myopia progression in real-world practice. 

The data showed that 95% of subjects wearing NaturalVue MF experienced a decrease in myopia progression as compared to baseline. Additionally, 78% of wearers showed a decrease in myopia progression of 70% or greater.  The average myopia progression slowed by approximately 0.85D or 85% compared to baseline, which was statistically significant at all points in time (P<0.05.)  The average myopia progression while wearing NaturalVue MF never exceeded more than about 0.25D from baseline. 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 what would be expected for a non-myopic child of a similar age range, and shows that NaturalVue MF contact lenses help to reduce the anatomical cause of myopia progression. 

The publication reported on the effectiveness of NaturalVue MF compared 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. This analysis demonstrated a Cumulative Absolute Reduction of axial Elongation (Termed a ‘CARE’ value) of 0.45 mm less axial elongation over three years for NaturalVue MF than would be expected for age- and ethnicity-matched children. 

To provide the eye care community and potential corporate partners with additional data, VTI has initiated PROTECT Clinical Study (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial), an international randomized controlled clinical trial (RCT) to test its NaturalVue Multifocal Contact Lenses in myopia progression control. The landmark study has enrolled patients in sites in Canada, the United States, and Hong Kong, and is in the process of adding sites in Singapore and Australia. VTI expects to have interim 1-year data from the PROTECT Clinical Study in the second half of 2023.   

“The data being published in Clinical Ophthalmology serves to unite optometry and ophthalmology to educate and inform to the latest research in the fight against myopia progression,” said Chief Medical Officer Kuang-mon (Ashley) Tuan, OD, PhD, FAAO. “We hope that eye care practitioners worldwide will appreciate the importance of our receiving validation from a highly respected and peer-reviewed journal for our real-world study.”  



*Statistically significant.

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