Ruilin Xiong1, Zhuoting Zhu2, Yu Jiang1, Wei Wang1, Jian Zhang1, Yanping Chen1, Gabriella Bulloch3, Yixiong Yuan1, Shiran Zhang1, Meng Xuan1, Junwen Zeng1, Mingguang He4. 1. State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, Guangdong, China. 2. State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, Guangdong, China; Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia. 3. Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia. 4. State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science, Guangdong Provincial Clinical Research Center for Ocular Diseases, Guangzhou, Guangdong, China; Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia; Ophthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia. Electronic address: mingguang_he@yahoo.com.
Abstract
PURPOSE: To evaluate longitudinal changes in macular choroidal thickness (mCT) in myopic children treated for one year with repeated low-level red-light (RLRL) therapy, and their predictive value for treatment efficacy on myopia control. DESIGN: A secondary analysis of data from a multicenter, randomized controlled trial (RCT,NCT04073238). PARTICIPANTS: Myopic children aged 8-13 years who participated in the RCT at 2 of 5 study sites where mCT measurements were available. METHODS: RLRL therapy was delivered using a home-use desktop light device which emitted red light at 650nm. CT was measured by swept-source optical coherence tomography at baseline and 1, 3, 6, and 12-months follow-ups. Visual acuity, axial length(AL), cycloplegic spherical equivalent refraction(SER), and treatment compliance were also measured. MAIN OUTCOME MEASURES: Changes in mCT at 1, 3, 6, and 12 months relative to baseline, and their associations with myopia control. RESULTS: A total of 120 children with available mCT data were included in the analysis (RLRL group:n=60; single-vison spectacle[SVS] group:n=60). Baseline characteristics were well balanced between the two groups. In the RLRL group, changes in mCT from baseline remained positive over one year, with a maximal increase of 14.755μm at 1 month and gradually reducing from 5.286μm at 3 months to 1.543μm at 6 months, finally reaching to 9.089μm at 12 months. In the SVS group mCT thinning was observed, with changes from baseline of -1.111μm, -8.212μm, -10.190μm, and -10.407μm at 1, 3, 6 and 12 months, respectively. Satisfactory myopia control was defined as annual progression rates of less than 0, 0.05, or 0.10 mm for AL, and less than 0, 0.25, or 0.50 D for SER. Models that included mCT changes at 3 months alone had acceptable predictive discrimination of satisfactory myopia control over 12 months, with areas under the curves(AUCs) of 0.710-0.786. The predictive performance of the models did not significantly improve after adding age, gender, and baseline AL or SER (AUCs ranged 0.740-0.865;P>0.05). CONCLUSIONS: This analysis from a multicenter RCT found RLRL therapy induced sustained choroidal thickening over the full course of treatment. Macular CT changes at 3 months alone can predict 12-month myopia control efficacy with reasonable accuracy.
PURPOSE: To evaluate longitudinal changes in macular choroidal thickness (mCT) in myopic children treated for one year with repeated low-level red-light (RLRL) therapy, and their predictive value for treatment efficacy on myopia control. DESIGN: A secondary analysis of data from a multicenter, randomized controlled trial (RCT,NCT04073238). PARTICIPANTS: Myopic children aged 8-13 years who participated in the RCT at 2 of 5 study sites where mCT measurements were available. METHODS: RLRL therapy was delivered using a home-use desktop light device which emitted red light at 650nm. CT was measured by swept-source optical coherence tomography at baseline and 1, 3, 6, and 12-months follow-ups. Visual acuity, axial length(AL), cycloplegic spherical equivalent refraction(SER), and treatment compliance were also measured. MAIN OUTCOME MEASURES: Changes in mCT at 1, 3, 6, and 12 months relative to baseline, and their associations with myopia control. RESULTS: A total of 120 children with available mCT data were included in the analysis (RLRL group:n=60; single-vison spectacle[SVS] group:n=60). Baseline characteristics were well balanced between the two groups. In the RLRL group, changes in mCT from baseline remained positive over one year, with a maximal increase of 14.755μm at 1 month and gradually reducing from 5.286μm at 3 months to 1.543μm at 6 months, finally reaching to 9.089μm at 12 months. In the SVS group mCT thinning was observed, with changes from baseline of -1.111μm, -8.212μm, -10.190μm, and -10.407μm at 1, 3, 6 and 12 months, respectively. Satisfactory myopia control was defined as annual progression rates of less than 0, 0.05, or 0.10 mm for AL, and less than 0, 0.25, or 0.50 D for SER. Models that included mCT changes at 3 months alone had acceptable predictive discrimination of satisfactory myopia control over 12 months, with areas under the curves(AUCs) of 0.710-0.786. The predictive performance of the models did not significantly improve after adding age, gender, and baseline AL or SER (AUCs ranged 0.740-0.865;P>0.05). CONCLUSIONS: This analysis from a multicenter RCT found RLRL therapy induced sustained choroidal thickening over the full course of treatment. Macular CT changes at 3 months alone can predict 12-month myopia control efficacy with reasonable accuracy.