Ophthalmology · 2025
Spatio-Temporal Optical Phase Kit for Myopia Control: Stage 1 Results from a Randomized Controlled Clinical Trial in Chinese Children.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Fedtke Cathleen, Chen Zhi, Tilia Daniel, Li Lihua, Chen Xiaoqin, Ehrmann Klaus, Lahav-Yacouel Karen, Falk Darrin, Conrad Fabian, Tan Kah Ooi, Bakaraju Ravi C
Аннотация
PURPOSE: The Spatio-Temporal Optical Phase (S.T.O.P.; nthalmic Pty Ltd) kit provides a dynamic optical cue using optical films on single-vision spectacles. This study assessed the efficacy of 2 S.T.O.P. kits (kits 1 and 2) in reducing myopia progression against single-vision spectacles without optical films (control group).
DESIGN: Prospective, multi-site, parallel-group, double-masked randomized controlled trial.
PARTICIPANTS: One hundred fifty-five participants completed the study (n = 50, 52, and 53 in the kit 1, kit 2, and control groups, respectively).
METHODS: One hundred sixty eligible children 6 to 14 years of age with myopia of between -0.75 diopter (D) and -5.00 D and astigmatism of 1.50 D or less were enrolled at the Fudan University Eye and ENT Hospital and Tianjin Eye Hospital between December 2023 and February 2025. Participants were assigned randomly to wear kit 1, kit 2, or no optical films (control group). Axial length (AL) was measured at baseline, at dispensing, and at 1, 4, and 6 months after dispensing. Cycloplegic autorefraction was measured at baseline and 6 months after dispensing. Differences between the control and each test group for changes in AL and spherical-equivalent cycloplegic autorefraction were analyzed using linear mixed models in the intention-to-treat population. Differences in visual acuity (VA) and subjective ratings were also assessed.
MAIN OUTCOME MEASURES: Change in AL from dispensing to the 6-month visit and change in spherical-equivalent cycloplegic autorefraction from baseline to the 6-month visit.
RESULTS: After 6 months, both S.T.O.P. kit groups showed significantly less change in AL than the control group. The estimated least-square mean differences (95% confidence intervals) compared with control for AL were: kit 1, -0.091 (-0.131 to -0.051) mm and kit 2, -0.090 (-0.130 to -0.050) mm and for spherical-equivalent cycloplegic autorefraction were: kit 1, 0.135 (0.003 to 0.268) D and kit 2, 0.134 (0.001 to 0.267) D. No significant differences were found between groups for VA or any subjective rating.
CONCLUSIONS: Both S.T.O.P. kit groups showed significantly less myopia progression compared with the control group while maintaining good visual performance. The S.T.O.P. kit's dynamic approach represents a promising strategy for myopia management.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
DESIGN: Prospective, multi-site, parallel-group, double-masked randomized controlled trial.
PARTICIPANTS: One hundred fifty-five participants completed the study (n = 50, 52, and 53 in the kit 1, kit 2, and control groups, respectively).
METHODS: One hundred sixty eligible children 6 to 14 years of age with myopia of between -0.75 diopter (D) and -5.00 D and astigmatism of 1.50 D or less were enrolled at the Fudan University Eye and ENT Hospital and Tianjin Eye Hospital between December 2023 and February 2025. Participants were assigned randomly to wear kit 1, kit 2, or no optical films (control group). Axial length (AL) was measured at baseline, at dispensing, and at 1, 4, and 6 months after dispensing. Cycloplegic autorefraction was measured at baseline and 6 months after dispensing. Differences between the control and each test group for changes in AL and spherical-equivalent cycloplegic autorefraction were analyzed using linear mixed models in the intention-to-treat population. Differences in visual acuity (VA) and subjective ratings were also assessed.
MAIN OUTCOME MEASURES: Change in AL from dispensing to the 6-month visit and change in spherical-equivalent cycloplegic autorefraction from baseline to the 6-month visit.
RESULTS: After 6 months, both S.T.O.P. kit groups showed significantly less change in AL than the control group. The estimated least-square mean differences (95% confidence intervals) compared with control for AL were: kit 1, -0.091 (-0.131 to -0.051) mm and kit 2, -0.090 (-0.130 to -0.050) mm and for spherical-equivalent cycloplegic autorefraction were: kit 1, 0.135 (0.003 to 0.268) D and kit 2, 0.134 (0.001 to 0.267) D. No significant differences were found between groups for VA or any subjective rating.
CONCLUSIONS: Both S.T.O.P. kit groups showed significantly less myopia progression compared with the control group while maintaining good visual performance. The S.T.O.P. kit's dynamic approach represents a promising strategy for myopia management.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.