Audrey Chia1, Wei-Han Chua1, Li Wen2, Allan Fong1, Yar Yen Goon3, Donald Tan4. 1. Singapore National Eye Center, Singapore; Singapore Eye Research Institute, Singapore. 2. Duke-National University of Singapore Graduate Medical School, Singapore; Singapore Clinical Research Institute, Singapore. 3. Singapore Eye Research Institute, Singapore. 4. Singapore National Eye Center, Singapore; Singapore Eye Research Institute, Singapore; Duke-National University of Singapore Graduate Medical School, Singapore; Department of Ophthalmology, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: donald.tan.t.h@snec.com.sg.
Abstract
PURPOSE: To study the change in spherical equivalent and other ocular parameters 1 year after stopping the administration of atropine. DESIGN: Prospective randomized double-masked clinical trial. METHODS: We assigned 400 myopic children, 6 to 12 years of age, to receiveatropine 0.5%, 0.1% or 0.01% for 24 months, after which medication was stopped. Parents and children gave informed consent to participate in the research. Children were reviewed at 26, 32 and 36 months, and changes in cycloplegic spherical equivalent (SE), axial length (AL), visual acuity, pupil size, and accommodation were assessed. RESULTS: Of the children, 356 (89%) entered into the washout phase. At entry, there was no significant difference in age, gender, SE, or AL among the children in the various atropine groups. Over the following 12 months, myopic progression was greater in the 0.5% eyes (-0.87 ± 0.52 D), compared to the 0.1% (-0.68 ± 0.45 D) and 0.01% eyes (-0.28 ± 0.33 D, P < 0.001). AL growth was also greater in the 0.5% (0.35 ± 0.20 mm) and 0.1% (0.33 ± 0.18 mm) eyes, compared to the 0.01% eyes (0.19 ± 0.13 mm, P < 0.001). Pupil size and near visual acuity returned to pre-atropine levels in all groups, but accommodation at 36 months was less in the 0.5% eyes (13.24 ± 2.72 D) compared to the 0.1% (14.45 ± 2.61 D) and 0.01% eyes (14.04 ± 2.90 D, P < 0.001). The overall increase in SE over the entire 36 months in the 0.5%, 0.1% and 0.01% groups was -1.15 ± 0.81 D, -1.04 ± 0.83 D and -0.72 ± 0.72 D, respectively (P < 0.001). CONCLUSION: There was a myopic rebound after atropine was stopped, and it was greater in eyes that had received 0.5% and 0.1% atropine. The 0.01% atropine effect, however, was more modulated and sustained.
RCT Entities:
PURPOSE: To study the change in spherical equivalent and other ocular parameters 1 year after stopping the administration of atropine. DESIGN: Prospective randomized double-masked clinical trial. METHODS: We assigned 400 myopic children, 6 to 12 years of age, to receive atropine 0.5%, 0.1% or 0.01% for 24 months, after which medication was stopped. Parents and children gave informed consent to participate in the research. Children were reviewed at 26, 32 and 36 months, and changes in cycloplegic spherical equivalent (SE), axial length (AL), visual acuity, pupil size, and accommodation were assessed. RESULTS: Of the children, 356 (89%) entered into the washout phase. At entry, there was no significant difference in age, gender, SE, or AL among the children in the various atropine groups. Over the following 12 months, myopic progression was greater in the 0.5% eyes (-0.87 ± 0.52 D), compared to the 0.1% (-0.68 ± 0.45 D) and 0.01% eyes (-0.28 ± 0.33 D, P < 0.001). AL growth was also greater in the 0.5% (0.35 ± 0.20 mm) and 0.1% (0.33 ± 0.18 mm) eyes, compared to the 0.01% eyes (0.19 ± 0.13 mm, P < 0.001). Pupil size and near visual acuity returned to pre-atropine levels in all groups, but accommodation at 36 months was less in the 0.5% eyes (13.24 ± 2.72 D) compared to the 0.1% (14.45 ± 2.61 D) and 0.01% eyes (14.04 ± 2.90 D, P < 0.001). The overall increase in SE over the entire 36 months in the 0.5%, 0.1% and 0.01% groups was -1.15 ± 0.81 D, -1.04 ± 0.83 D and -0.72 ± 0.72 D, respectively (P < 0.001). CONCLUSION: There was a myopic rebound after atropine was stopped, and it was greater in eyes that had received 0.5% and 0.1% atropine. The 0.01% atropine effect, however, was more modulated and sustained.