Abstract
AIM: To investigate efficacy and ocular surface safety of 3 kinds of different correction methods for correction of high myopia in adolescents. METHODS: A prospective, randomized, controlled clinical trial was conducted. From January 2022 to December 2022, 62 adolescents with high myopia (124 eyes) were recruited, with spherical refractive errors ranging from -6.00 to -7.50 diopters (D) and refractive astigmatism ≤1.50 D. All participants were randomly assigned to three groups: the orthokeratology combined with single-vision spectacle lenses (OK+SVLs) group (20 cases, 40 eyes), the peripheral defocus rigid gas permeable contact lenses (Defocus RGPCL) group (22 cases, 44 eyes), and the single-vision spectacle lenses (SVLs) group (20 cases, 40 eyes). All of them were followed up for 1.5y. The observation indicators included refractive error, axial length (AL), tear break-up time (BUT), percentage of hexagonal corneal endothelial cells (CEC), CEC density, and ocular surface adverse reactions. RESULTS: The three groups had mean age of 14.84±1.87y, 14.57±1.91y, and 14.80±1.52y, respectively. No statistically significant differences were found in age, gender, corneal curvature, AL, and spherical equivalent among the groups (all P>0.05). At the 6mo, 1, and 1.5y follow-ups after spectacle lens wear, the improvements in refractive error in the OK+SVLs and Defocus RGPCL groups were significantly superior to those in the SVLs group (F=4.221, P=0.017; F=7.226, P=0.001; F=16.140, P<0.001), while no significant difference was observed between the OK+SVLs and Defocus RGPCL groups (all P>0.05). Intergroup comparisons of AL changes revealed statistically significant differences at all follow-up time points (F=3.493, P=0.034; F=9.930, P<0.001; F=20.570, P<0.001), with no notable difference between the OK+SVLs and Defocus RGPCL groups (all P>0.05). After 1.5y of lens wear, the intergroup comparison of BUT showed a statistically significant difference (F=5.783, P=0.004), whereas no significant differences were found in the percentage of hexagonal CEC and CEC density among the three groups (all P>0.05). No severe complications were observed in the two contact lens groups; only 5 eyes presented with grade 1 or 2 bulbar conjunctival hyperemia and corneal epithelial staining. All adverse reactions were well controlled by temporary lens discontinuation or medication, and resumed lens wear subsequently, with no statistically significant difference in the incidence of adverse reactions between the two contact lens groups (P>0.05). CONCLUSION: Orthokeratology lenses and peripheral defocus RGPCL yield better visual acuity correction and superior image quality, which can minimize retinal image aberrations induced by high refractive errors. Both interventions achieve satisfactory corrective vision and effective myopia control effects in adolescents with high myopia, with no significant adverse reactions observed during the follow-up period, indicating a high level of wearing safety for clinical application.