VTI’s NaturalVue Multifocal contact lens is “emerging as a single lens that can support patients through every stage of life”, according to data from two studies presented at the American Academy of Optometry meeting in Boston.
Minimising Myopia Progression
Final year two data from the ongoing three-year PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens Trial) study were summarised in a presentation by Dr Ashley Tuan, Chief Medical Officer of VTI.
In her presentation, entitled ‘New evidence uncovered: 2-year RCT findings in myopia management, astigmatism, and vision outcomes with Naturalvue’, Dr Tuan reported that myopia progression minimisation continued over two years with:
- Refractive error treatment effect: 0.59 \D slowing of myopia,*
- Axial length treatment effect: 0.22 mm reduction in axial length elongation, and*
- Nearly two thirds of patients had only near emmetropic change in axial length.
On the outcomes of continuous treatment regardless of pupil size, Dr Tuan reported:
- Proven efficacy through year two across pupil sizes (2–7 mm), ideal for children active outdoors or on digital devices,
- Larger pupils received enhanced treatment effects, strengthening myopia management, and
- Nearly two thirds of children achieved near emmetropic change.
With two years of randomised clinical trial results, combined with real-world studies, we now have one of the most comprehensive data sets in myopia management
Note: The average indoor pupil size is 5.5 to 6.0 mm, but the range is about 2 mm to 8mm.1,2 A study from another myopia management lens design shows that if the pupil is <3.4 mm, combined with low wear time, efficacy may drop.3
Dr Tuan said the study had demonstrated normalised accommodative accuracy, noting that the VTI lens:
- Preserved normal accommodation responses,
- Reduced both accommodative lead and excessive lag, bringing the accommodative response into a more typical and relaxed state, and
- Sustainably improved wearer’s accommodative state through year two.
Dr Tuan said the myopia management results reflect the adjusted data set, equalised for key variables such as age, sex, and region.
Both two-year adjusted treatment effect values were consistent with the two-year values achieved by the only United States Food and Drug Administration (FDA) approved therapy for myopia progression control.
Vision, Comfort, and Safety
Dr Tuan reported “uncompromised vision and comfort with 20/20 distance and near visual acuity (VA) maintained, comparable to spectacles and low-contrast VA equivalent to single-vision contact lenses”.
Children reported high satisfaction,** matching single vision lenses, with no trade-offs in vision or comfort. Stereoacuity was preserved.
Furthermore, Dr Tuan reported that children achieved comfortable wearing time of 11–12 hours per day and there were no serious device-related adverse events.
Correcting for Astigmatism
Dr Tuan also shared an update on the performance of NaturalVue Enhanced Multifocal for astigmatism. The data was derived from the clinical study ‘Evaluation of visual acuity with multifocal catenary curve-based contact lens design in different degrees of astigmatism’, conducted by University Complutense of Madrid, Spain.
This study found that NaturalVue Enhanced Multifocal proved a strong degree of astigmatic compatibility:
- The lens was proven to correct 100% astigmatism to 3.00D,***
- Of patients, 100% achieved 20/20 or better binocular vision, and
- Stereopsis was maintained and the lens adapted to all pupil sizes.
Combined with previously published six-year retrospective data and independent studies, VTI said these findings affirm NaturalVue Multifocal’s effectiveness in controlling myopia progression.
“The two-year PROTECT results highlight what makes NaturalVue truly unique: its proprietary omnifocal design creates an extended depth of focus channel that works with the way the brain naturally processes visual information,” said Dr Tuan. “The Neurofocus Optics technology, featuring unique extended depth of focus functionality, is the driver behind the strong effects on slowing the progression of myopia and axial elongation across pupil sizes; in addition, it has also shown that wearing NaturalVue Multifocal may help children with atypical accommodative responses move into the normal range.
“We’re delivering meaningful myopia progression management and preserving vision.”
Chief Executive Officer and Executive Director of VTI, Dr Juan Carlos Aragón added, “With two years of randomised clinical trial results, combined with real-world studies, we now have one of the most comprehensive data sets in myopia management.
“NaturalVue Multifocal is emerging as a single lens that can support patients through every stage of life – from childhood myopia to digital eye strain, presbyopia, and astigmatism. That makes it uniquely positioned to meet the real-world vision needs of patients, and to support practitioners who care for them.”
NaturalVue multifocal contact lenses are exclusively distributed in Australia and New Zealand by Gelflex. Visit: gelflex.com.
*Adjusted data, equalised for key variables such as age, sex, and pupil size. Data reflects Planned Subgroup ages 8–12 and power range of -0.75 to -4.00.
** Validated patient-reported outcome PREP2 survey (Pediatric refractive error profile 2)
*** When following the NaturalVue fitting guide.
References
- Brown JT, Connelly M, Neville KA, et al. Developmental changes of normal pupil size and reactivity in children. J Pediatr Ophthalmol Strabismus. 2015 May-Jun;52(3):147-51. doi: 10.3928/01913913-20150317-11.
- Silbert J, Matta N, Silbert DI, et al. Pupil size and anisocoria in children measured by the plusoptiX photoscreener. J AAPOS. 2013 Dec;17(6):609-11. doi: 10.1016/j.jaapos.2013.09.003.
- Li Q, Fang F. Advances and challenges of soft contact lens design for myopia control. Appl Opt. 2019 Mar 1;58(7):1639-1656. doi: 10.1364/AO.58.001639.
