Fitting efficacy and ocular surface safety of digitally customized orthokeratology lenses in patients with moderate myopia and high curvature corneas.

PURPOSE: To investigate fitting characteristics, ocular surface safety, and myopia control efficacy of digitally customized orthokeratology (OK) lenses in moderate myopia patients with high curvature corneas (flat K ≥ 44 D), with low-concentration atropine as an adjunct.

METHODS

126 patients were randomized into three groups: Group A (digitally customized OK lenses + 0.01% atropine, n = 42), Group B (conventional OK lenses + 0.01% atropine, n = 41), and Group C (single-vision spectacles, n = 43). Primary outcomes included fitting qualification rate, corneal epithelial integrity, and tear film stability; axial length change was a key secondary outcome. Multiple linear regression and sensitivity analysis were performed.

RESULTS

Group A had a significantly higher fitting qualification rate than Group B (1 month: 95.2% vs 80.5%, P = 0.031; 12 months: 88.1% vs 73.2%, P = 0.068). It also showed better corneal epithelial integrity, tear film stability, and slower axial elongation than Groups B and C (all P < 0.05). Fitting qualification rate and intervention type were key predictors of axial length growth.

CONCLUSION

Digitally customized orthokeratology lenses combined with 0.01% atropine can significantly improve the fitting accuracy for high curvature corneas. Corneal epithelial integrity is ensured by maintaining corneal epithelial thickness and reducing corneal fluorescein staining scores. Meanwhile, this combined intervention optimizes tear film stability, ensures ocular surface safety and achieves favorable myopia control efficacy. This combined regimen is recognized as an optimal contact lens correction option for myopia patients with high curvature corneas. The adjunctive effect of low-concentration atropine needs to be further verified in combination with lens fitting status.