Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China
Introduction Assessment of near work-induced transient myopia (NITM) is important for permanent myopia development and progression. Atropine eye drop has been reported to be beneficial in reducing initial NITM and slowing down myopic progression. This study aimed to investigate the efficacy of 0.01%...
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BMJ Publishing Group
2023-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e079833.full |
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| author | Sile Yu Wei He Lan Hu Ling Xu Jiayan Chen Guanghao Qin Yifan Qi Emmanuel Eric Pazo Xingru He |
| author_facet | Sile Yu Wei He Lan Hu Ling Xu Jiayan Chen Guanghao Qin Yifan Qi Emmanuel Eric Pazo Xingru He |
| author_sort | Sile Yu |
| collection | DOAJ |
| description | Introduction Assessment of near work-induced transient myopia (NITM) is important for permanent myopia development and progression. Atropine eye drop has been reported to be beneficial in reducing initial NITM and slowing down myopic progression. This study aimed to investigate the efficacy of 0.01% atropine in treating NITM and its possible association with the progression of refractive change in Chinese myopic children.Methods and analysis The study is designed as a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial conducted at He Eye Specialist Hospital in Shenyang, China. One hundred fifty participants will be randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for 1 year. Initial NITM, cycloplegic refraction, axial length, best-corrected visual acuity, intraocular pressure and pupil diameter will be measured at baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks. Visual Function Questionnaire will be administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit.Ethics and dissemination A parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression registered on 10 September 2023. Ethics approval number: IRB (2023) K025.01. The study’s findings will be shared regardless of the effect’s direction.Trial registration number NCT06034366. |
| format | Article |
| id | doaj-art-b6b44591f0434d55aa986de99df0370f |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
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| spelling | doaj-art-b6b44591f0434d55aa986de99df0370f2025-08-20T03:11:11ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-079833Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in ChinaSile Yu0Wei He1Lan Hu2Ling Xu3Jiayan Chen4Guanghao Qin5Yifan Qi6Emmanuel Eric Pazo7Xingru He8School of Public Health, He University, Shenyang, ChinaDepartment of Ophthalmology, He Eye Specialist Hospital, Shenyang, ChinaDepartment of Neurology, First Affiliated Hospital, Hainan Medical University, Haikou, Hainan, ChinaDepartment of Ophthalmology, He Eye Specialist Hospital, Shenyang, ChinaHe Eye Specialist Hospital, Shenyang, ChinaHe Eye Specialist Hospital, Shenyang, ChinaDepartment of Ophthalmology, He Eye Specialist Hospital, Shenyang, ChinaTianjin Medical University Eye Hospital, Tianjin, ChinaDepartment of Ophthalmology, He Eye Specialist Hospital, Shenyang, ChinaIntroduction Assessment of near work-induced transient myopia (NITM) is important for permanent myopia development and progression. Atropine eye drop has been reported to be beneficial in reducing initial NITM and slowing down myopic progression. This study aimed to investigate the efficacy of 0.01% atropine in treating NITM and its possible association with the progression of refractive change in Chinese myopic children.Methods and analysis The study is designed as a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial conducted at He Eye Specialist Hospital in Shenyang, China. One hundred fifty participants will be randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for 1 year. Initial NITM, cycloplegic refraction, axial length, best-corrected visual acuity, intraocular pressure and pupil diameter will be measured at baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks and 48 weeks. Visual Function Questionnaire will be administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit.Ethics and dissemination A parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression registered on 10 September 2023. Ethics approval number: IRB (2023) K025.01. The study’s findings will be shared regardless of the effect’s direction.Trial registration number NCT06034366.https://bmjopen.bmj.com/content/13/12/e079833.full |
| spellingShingle | Sile Yu Wei He Lan Hu Ling Xu Jiayan Chen Guanghao Qin Yifan Qi Emmanuel Eric Pazo Xingru He Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China BMJ Open |
| title | Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China |
| title_full | Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China |
| title_fullStr | Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China |
| title_full_unstemmed | Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China |
| title_short | Protocol for a parallel assignment prospective, randomised, double-blinded, placebo-controlled trial to evaluate the efficacy of 0.01% atropine for near work-induced transient myopia and myopic progression in China |
| title_sort | protocol for a parallel assignment prospective randomised double blinded placebo controlled trial to evaluate the efficacy of 0 01 atropine for near work induced transient myopia and myopic progression in china |
| url | https://bmjopen.bmj.com/content/13/12/e079833.full |
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