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Comparison of trial lens and computer-aided fitting in orthokeratology: A multi-center, randomized, examiner-masked, controlled study

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机构: [1]Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Laboratory, Beijing, China [2]Department of Ophthalmology & Clinical Centre of Optometry, Peking University People’s Hospital, Beijing, China [3]Eye Disease and Optometry Institute, Peking University People’s Hospital, Beijing, China [4]College of Optometry, Peking University Health Science Center, Beijing, China [5]Beijing Key Laboratory of the Diagnosis and Therapy of Retinal and Choroid Diseases, Beijing, China [6]Beijing Friendship Hospital, Capital Medical University, Beijing, China [7]Beijing Key Laboratory of Intraocular Tumor Diagnosis and Treatment, Medical Artificial Intelligence Research and Verification Key Laboratory of the Ministry of Industry and Information Technology, Beijing, China
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关键词: Orthokeratology Contact lens Computer-aided fitting Myopia Visual acuity Axial length

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To compare the efficacy and safety between traditional lens fitting and computer-aided fitting methods for orthokeratology (OrthoK) in the Chinese population.A multi-center, examiner-masked, randomized controlled study was conducted with a one-year follow-up period, enrolling 280 participants with spherical equivalent (SE) ranging from -0.5D to -4.0D. Participants were assigned to either the computer-aided orthokeratology fitting group (trial group) or the traditional lens fitting group (control group) using stratified randomization based on age (8 to 13 years, 13 to 18 years, and ≥ 18 years) to ensure a minimum of 30 cases in each sub-age group. Ocular examinations included visual acuity, objective and subjective refraction, corneal endothelial cell density, corneal topography, intraocular pressure, axial length, and ocular health assessment. Successful lens-correction was defined as the residual refraction with the OK lens, which should not exceed ± 0.5D, and/or an uncorrected visual acuity of no worse than 0.1 logMAR. Statistical analysis involves t-tests, analysis of variance, and Chi-squared tests.215 subjects were included in the statistical analysis (109 in the trial group and 106 in the control group). In both groups, compared to baseline data, the uncorrected visual acuity (UCVA) improved significantly, with SE reduced and central corneal curvature flattened greatly after wearing OrthoK lens (P < 0.05 for all). Compared to the control group, the trial group exhibited a higher successful rate in correcting UCVA (93.6 % vs. 84.0 %, P = 0.03) and slightly better correction in refraction (77.1 % vs. 66.0 %, P = 0.07) at 1-month follow-up. However, no significant differences were observed in the axial length elongation, corneal changes, or the incidence of adverse events between the two groups.These findings indicate the higher efficiency and slightly better performance in correcting myopia and improving UCVA of computer-aided lens fitting approach compared to the traditional one, but similar outcomes in controlling axial elongation.Copyright © 2024. Published by Elsevier Ltd.

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出版当年[2023]版:
大类 | 3 区 医学
小类 | 2 区 眼科学
最新[2023]版:
大类 | 3 区 医学
小类 | 2 区 眼科学
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出版当年[2022]版:
Q2 OPHTHALMOLOGY
最新[2023]版:
Q1 OPHTHALMOLOGY

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第一作者机构: [1]Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Laboratory, Beijing, China
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通讯机构: [1]Beijing Tongren Eye Center, Beijing Tongren Hospital, Capital Medical University, Beijing Ophthalmology & Visual Sciences Key Laboratory, Beijing, China [2]Department of Ophthalmology & Clinical Centre of Optometry, Peking University People’s Hospital, Beijing, China [3]Eye Disease and Optometry Institute, Peking University People’s Hospital, Beijing, China [4]College of Optometry, Peking University Health Science Center, Beijing, China [5]Beijing Key Laboratory of the Diagnosis and Therapy of Retinal and Choroid Diseases, Beijing, China [7]Beijing Key Laboratory of Intraocular Tumor Diagnosis and Treatment, Medical Artificial Intelligence Research and Verification Key Laboratory of the Ministry of Industry and Information Technology, Beijing, China
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