November 12, 2024
Photo Credit: Getty Images
INDIANAPOLIS — At the American Academy of Optometry Meeting, Visioneering Technologies Inc. (VTI) shared new findings from Year One of the ongoing PROTECT (PROgressive Myopia Treatment Evaluation for NaturalVue Multifocal Contact Lens) clinical trial.
The PROTECT study, a randomized, double-masked, controlled clinical trial, evaluates the safety and effectiveness of NaturalVue Multifocal lenses for managing myopia progression in children. The latest insights were presented by Dr. Kuang-mon (Ashley) Tuan, VTI’s Chief Medical Officer, during two key sessions: 1) “Accommodative Accuracy of Children Wearing Catenary Curve Multifocal Lenses” highlighted the lens’s high magnitude of relative plus not only has no negative impact on children’s accommodative accuracy, but it may improve its performance on accommodative accuracy. 2) “New Insights from the PROTECT Trial” covered patient-reported outcomes, reinforcing the lens’s comfort and efficacy for long-term myopia control.
Key Findings:
- Children’s Quality of Life with NaturalVue Multifocal Lenses
- Comfort and Satisfaction: Results from the validated Patient Reported Outcome PREP2 reveal that children wearing NaturalVue Multifocal lenses reported the same high level of satisfaction with no noticeable compromise in vision or comfort as children wearing single vision contact lenses. These results corroborate PROTECT’s clinical visual outcomes and, reflected in the wearing time, that there was no difference compared to single vision contact lenses.
- Year One Treatment Outcomes: Children experienced significant reductions in refractive error and axial length progression, regardless of pupil size.
- Accommodative Accuracy and Binocular Vision
- Enhanced Vision Accuracy: NaturalVue Multifocal lenses normalize accommodative accuracy in children struggling with near focus, with no negative impact on accommodative accuracy. This benefit enhances overall visual performance, critical for children’s day-to-day tasks.
Additional Highlights from Year One Data:
- Reduction in Myopia Progression: 89% (0.48D) reduction in refractive error progression and a 0.17 mm (58%) reduction in axial elongation (vs. control; adjusted for age, sex, site and pupil size) emphasizing the lens’s effectiveness. Unadjusted analysis reported 71% (0.41 D) reduction in refractive error progression and similar to the 61% (0.17 mm) axial length reduction.
- Performance Can Be Expected Across Pupil Sizes: The lens provides continuous treatment benefits, regardless of individual children’s pupil sizes and constricted pupil in bright sunlight.
- High Compliance: Children wore the lenses for an average of 11-12 hours per day, with a low dropout rate (4%), signaling excellent comfort and compliance.
In addition, two posters presented at the meeting included Patient Reported Outcomes and further evidence supporting NaturalVue Multifocal’s Neurofocus Optics technology, with applications for both myopia and presbyopia management.
VTI plans to release Year Two data from the three-year PROTECT trial in early 2025. These findings, combined with previous data from independent studies, continue to support NaturalVue Multifocal’s effectiveness in controlling myopia progression across diverse patient populations.
