Short-Term Exposure to Violet Light Emitted from Eyeglass Frames in Myopic Children: A Randomized Pilot Clinical Trial

Violet light (VL), 360–400 nm wavelength, is contained in the sunlight and is an effective element for myopia suppression. This study is to investigate the safety and efficacy of novel eyeglasses that emit VL from the frames. This is a double-masked, randomized, pilot clinical trial conducted in a c...

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Main Authors: Hidemasa Torii, Kiwako Mori, Takashi Okano, Shinichiro Kondo, Hao-Yung Yang, Erisa Yotsukura, Akiko Hanyuda, Mamoru Ogawa, Kazuno Negishi, Toshihide Kurihara, Kazuo Tsubota
Format: Article
Language:English
Published: MDPI AG 2022-10-01
Series:Journal of Clinical Medicine
Subjects:
Online Access:https://www.mdpi.com/2077-0383/11/20/6000
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author Hidemasa Torii
Kiwako Mori
Takashi Okano
Shinichiro Kondo
Hao-Yung Yang
Erisa Yotsukura
Akiko Hanyuda
Mamoru Ogawa
Kazuno Negishi
Toshihide Kurihara
Kazuo Tsubota
author_facet Hidemasa Torii
Kiwako Mori
Takashi Okano
Shinichiro Kondo
Hao-Yung Yang
Erisa Yotsukura
Akiko Hanyuda
Mamoru Ogawa
Kazuno Negishi
Toshihide Kurihara
Kazuo Tsubota
author_sort Hidemasa Torii
collection DOAJ
description Violet light (VL), 360–400 nm wavelength, is contained in the sunlight and is an effective element for myopia suppression. This study is to investigate the safety and efficacy of novel eyeglasses that emit VL from the frames. This is a double-masked, randomized, pilot clinical trial conducted in a clinic in Japan. Forty-three children with myopia were enrolled. Participants were randomly assigned to two groups, wearing VL-emitting eyeglass frames (VLf) that emitted VL of 310 μW/cm<sup>2</sup> (VLf group, <i>n</i> = 22) or pseudo-placebo eyeglass frames with a minimal emission of VL (<10 μW/cm<sup>2</sup>) (control group, <i>n</i> = 21). The exposure time was 3 h per day. The primary outcomes were visual acuity, tear film break-up time, corneal endothelial cell density, and the slit-lamp/fundus examinations. The secondary outcome was the 6-month changes in the axial lengths and cycloplegic refractions. Forty-one (95%) participants were included; twenty-one in the VLf group and twenty in the control group. No significant differences were seen in any safety evaluation. Significant changes were seen in axial elongation, choroidal thickness, and cycloplegic refractions in the subgroup analysis of 8- to 10-year-old children (<i>p</i> < 0.05), but otherwise no significant differences were seen. The VLf showed short-term safety and effectiveness against myopia progression.
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spelling doaj.art-471b243bf3c34648b5981f6a9a30cc592023-11-24T00:39:17ZengMDPI AGJournal of Clinical Medicine2077-03832022-10-011120600010.3390/jcm11206000Short-Term Exposure to Violet Light Emitted from Eyeglass Frames in Myopic Children: A Randomized Pilot Clinical TrialHidemasa Torii0Kiwako Mori1Takashi Okano2Shinichiro Kondo3Hao-Yung Yang4Erisa Yotsukura5Akiko Hanyuda6Mamoru Ogawa7Kazuno Negishi8Toshihide Kurihara9Kazuo Tsubota10Department of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanDepartment of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanSmile Eye Clinic, Kanzeme Building 4F, 1-6-12 Aoba-ku, Yokohama 227-0062, JapanDepartment of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanSmile Eye Clinic, Kanzeme Building 4F, 1-6-12 Aoba-ku, Yokohama 227-0062, JapanDepartment of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanDepartment of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanDepartment of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanDepartment of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanDepartment of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanDepartment of Ophthalmology, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, JapanViolet light (VL), 360–400 nm wavelength, is contained in the sunlight and is an effective element for myopia suppression. This study is to investigate the safety and efficacy of novel eyeglasses that emit VL from the frames. This is a double-masked, randomized, pilot clinical trial conducted in a clinic in Japan. Forty-three children with myopia were enrolled. Participants were randomly assigned to two groups, wearing VL-emitting eyeglass frames (VLf) that emitted VL of 310 μW/cm<sup>2</sup> (VLf group, <i>n</i> = 22) or pseudo-placebo eyeglass frames with a minimal emission of VL (<10 μW/cm<sup>2</sup>) (control group, <i>n</i> = 21). The exposure time was 3 h per day. The primary outcomes were visual acuity, tear film break-up time, corneal endothelial cell density, and the slit-lamp/fundus examinations. The secondary outcome was the 6-month changes in the axial lengths and cycloplegic refractions. Forty-one (95%) participants were included; twenty-one in the VLf group and twenty in the control group. No significant differences were seen in any safety evaluation. Significant changes were seen in axial elongation, choroidal thickness, and cycloplegic refractions in the subgroup analysis of 8- to 10-year-old children (<i>p</i> < 0.05), but otherwise no significant differences were seen. The VLf showed short-term safety and effectiveness against myopia progression.https://www.mdpi.com/2077-0383/11/20/6000myopiaviolet lightrandomized double-blind placebo-controlled clinical trialsafetyefficacy
spellingShingle Hidemasa Torii
Kiwako Mori
Takashi Okano
Shinichiro Kondo
Hao-Yung Yang
Erisa Yotsukura
Akiko Hanyuda
Mamoru Ogawa
Kazuno Negishi
Toshihide Kurihara
Kazuo Tsubota
Short-Term Exposure to Violet Light Emitted from Eyeglass Frames in Myopic Children: A Randomized Pilot Clinical Trial
Journal of Clinical Medicine
myopia
violet light
randomized double-blind placebo-controlled clinical trial
safety
efficacy
title Short-Term Exposure to Violet Light Emitted from Eyeglass Frames in Myopic Children: A Randomized Pilot Clinical Trial
title_full Short-Term Exposure to Violet Light Emitted from Eyeglass Frames in Myopic Children: A Randomized Pilot Clinical Trial
title_fullStr Short-Term Exposure to Violet Light Emitted from Eyeglass Frames in Myopic Children: A Randomized Pilot Clinical Trial
title_full_unstemmed Short-Term Exposure to Violet Light Emitted from Eyeglass Frames in Myopic Children: A Randomized Pilot Clinical Trial
title_short Short-Term Exposure to Violet Light Emitted from Eyeglass Frames in Myopic Children: A Randomized Pilot Clinical Trial
title_sort short term exposure to violet light emitted from eyeglass frames in myopic children a randomized pilot clinical trial
topic myopia
violet light
randomized double-blind placebo-controlled clinical trial
safety
efficacy
url https://www.mdpi.com/2077-0383/11/20/6000
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