Hiroyuki Kanda1, Tetsuro Oshika2, Takahiro Hiraoka2, Satoshi Hasebe3, Kyoko Ohno-Matsui4, Satoshi Ishiko5, Osamu Hieda6, Hidemasa Torii7, Saulius R Varnas8, Takashi Fujikado9. 1. Department of Applied Visual Science, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. 2. Department of Ophthalmology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan. 3. Department of Ophthalmology, Kawasaki Medical University, Kurashiki, Japan. 4. Department of Ophthalmology and Visual Science, Tokyo Medical and Dental University, Tokyo, Japan. 5. Department of Medicine and Engineering Combined Research Institute, Asahikawa Medical University, Asahikawa, Japan. 6. Department of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan. 7. Department of Ophthalmology, Keio University School of Medicine, Tokyo, Japan. 8. ZEISS-Business Group Vision Care, Technology and Innovation, Adelaide, Australia. 9. Department of Applied Visual Science, Osaka University Graduate School of Medicine, 2-2 Yamadaoka, Suita, Osaka, 565-0871, Japan. fujikado@ophthal.med.osaka-u.ac.jp.
Abstract
PURPOSE:Novel spectacle lenses (MyoVision, Carl Zeiss) designed to reduce relative peripheral hyperopia have been developed and reported to be effective for preventing myopia progression in a subgroup of Chinese children. In this study we examined the efficacy of MyoVision lenses in Japanese children. STUDY DESIGN: This was a multicenter prospective randomized double-blind placebo-controlled trial. METHOD: We enrolled 207 participants (aged 6-12 years) with spherical equivalent refractions (SERs) ranging from -1.5 to -4.5 diopters (D) and with at least 1 myopic parent. The participants were randomized to receive either single vision lenses (SVLs) or MyoVision lenses and were followed up every 6 months for 2 years. The primary outcome was myopia progression evaluated by cycloplegic autorefraction, and the secondary outcome was elongation of axial length. RESULTS: A total of 203 children (98.1%) completed the follow-up. The mean adjusted change in SER was -1.43 ± 0.10 D in the MyoVision group, which was not significantly different from that of the control group wearing SVLs (-1.39 ± 0.07 D) at the 24-month visit (P = .65). The adjusted axial length elongation was 0.73 ± 0.04 mm in the MyoVision group, which was not significantly different from that in the control group wearing SVLs (0.69 ± 0.03 mm) at the 24-month visit (P = .28). CONCLUSION: The results of this clinical trial could not verify the therapeutic effect of MyoVision for slowing down myopia progression in Japanese children. Additional studies are needed to design lenses that can reduce peripheral hyperopic defocus individually and to examine the effectiveness of these lenses in preventing myopia progression.
RCT Entities:
PURPOSE: Novel spectacle lenses (MyoVision, Carl Zeiss) designed to reduce relative peripheral hyperopia have been developed and reported to be effective for preventing myopia progression in a subgroup of Chinese children. In this study we examined the efficacy of MyoVision lenses in Japanese children. STUDY DESIGN: This was a multicenter prospective randomized double-blind placebo-controlled trial. METHOD: We enrolled 207 participants (aged 6-12 years) with spherical equivalent refractions (SERs) ranging from -1.5 to -4.5 diopters (D) and with at least 1 myopic parent. The participants were randomized to receive either single vision lenses (SVLs) or MyoVision lenses and were followed up every 6 months for 2 years. The primary outcome was myopia progression evaluated by cycloplegic autorefraction, and the secondary outcome was elongation of axial length. RESULTS: A total of 203 children (98.1%) completed the follow-up. The mean adjusted change in SER was -1.43 ± 0.10 D in the MyoVision group, which was not significantly different from that of the control group wearing SVLs (-1.39 ± 0.07 D) at the 24-month visit (P = .65). The adjusted axial length elongation was 0.73 ± 0.04 mm in the MyoVision group, which was not significantly different from that in the control group wearing SVLs (0.69 ± 0.03 mm) at the 24-month visit (P = .28). CONCLUSION: The results of this clinical trial could not verify the therapeutic effect of MyoVision for slowing down myopia progression in Japanese children. Additional studies are needed to design lenses that can reduce peripheral hyperopic defocus individually and to examine the effectiveness of these lenses in preventing myopia progression.
Authors: Brien A Holden; Timothy R Fricke; David A Wilson; Monica Jong; Kovin S Naidoo; Padmaja Sankaridurg; Tien Y Wong; Thomas J Naduvilath; Serge Resnikoff Journal: Ophthalmology Date: 2016-02-11 Impact factor: 12.079
Authors: Monica Jong; Jost B Jonas; James S Wolffsohn; David A Berntsen; Pauline Cho; Danielle Clarkson-Townsend; Daniel I Flitcroft; Kate L Gifford; Annechien E G Haarman; Machelle T Pardue; Kathryn Richdale; Padmaja Sankaridurg; Milly S Tedja; Christine F Wildsoet; Joan E Bailey-Wilson; Jeremy A Guggenheim; Christopher J Hammond; Jaakko Kaprio; Stuart MacGregor; David A Mackey; Anthony M Musolf; Caroline C W Klaver; Virginie J M Verhoeven; Veronique Vitart; Earl L Smith Journal: Invest Ophthalmol Vis Sci Date: 2021-04-28 Impact factor: 4.799