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

Purpose: To compare the efficacy and safety between traditional lens fitting and computer-aided fitting methods for orthokeratology (OrthoK) in the Chinese population.

Methods: 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.

Results: 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.

Conclusion: 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.