RESUMO
Myopia control efficacy and long-term safety of the Breath-O-Correct orthokeratology (OK) lens was evaluated in a 2-year randomized, single vision (SV) spectacle lens-controlled, single-blind clinical trial combining clinical and tear proteomics data. A total of 71 children (43 OK, 9.8 ± 1.3 years; 28 SV, 9.5 ± 1.4 years) completed the 2-year study. Axial length (AL), cycloplegic refraction, clinical safety parameters (best-corrected visual acuity, central cornea thickness, corneal endothelial health, ocular surface disease index), and quantitative tear proteomics were evaluated by masked examiners. Mean 2-year-normalized AL elongations in the OK and SV groups differed significantly (p = 0.03) and were 0.37 ± 0.37 mm and 0.60 ± 0.41 mm, respectively. OK-mediated myopia control efficacy was 37.1%. No significant difference was found in clinical safety parameters of both groups (p > 0.10), except for a thinner central corneal thickness in the OK group (p = 0.01). Proteomics revealed modest OK lens-mediated effects on immune response proteins, including an increased abundance of haptoglobin at 6 and 12 months and a decreased abundance of two proteins (neutrophil defensin 3 and histone 4) at 6 months. The changes were further validated using a high-resolution multiple-reaction monitoring (MRMHR) mass spectrometry. In summary, the Breath-O-Correct OK lens significantly reduced AL elongation in schoolchildren without adverse clinical effects or subclinical inflammatory responses.
RESUMO
Purpose: This study evaluated the efficacy and ocular surface status of Breath-O Correct, novel orthokeratology (OK) lenses, worn overnight for 3 months. Lens-induced changes in the tear proteome were evaluated. Methods: Thirty-one subjects, aged 19 to 26 years with refractive error from -1.00 to -5.00 D, were randomly assigned 1:1 to the treatment or control group. Refraction, visual acuity, corneal integrity, biomechanics and endothelial health, ocular surface changes, and subjective symptoms were assessed at the baseline, one-month, and three-month visits. The tear proteome was characterized over time using sequential window acquisition of all theoretical ion spectra mass spectrometry. Results: Lenses improved uncorrected visual acuity and reduced spherical powers with similar efficacy to other OK lenses. Significant reductions (P < 0.05) in corneal hysteresis (11.12 ± 1.12 to 10.38 ± 1.36 mm Hg) and corneal resistance factor (11.06 ± 1.32 to 9.90 ± 1.45 mm Hg) were observed in the treatment group after one month of lens wear, whereas other assessed factors remained unchanged. Thirteen and eight differentially expressed proteins were found after one month and three months of lens wear, respectively. Two proteins (proline-rich protein 27 and immunoglobulin V regions) were differentially expressed at both visits. Conclusions: Over a three-month period, Breath-O Correct lenses were overall safe, well tolerated, efficacious in refractive power reduction, and comparable with other OK lenses. Furthermore, their use caused only minor noninflammatory protein expression changes in the tear proteome. Translational Relevance: This study investigated the safety of orthokeratology contact lenses on the ocular surface in molecular aspects and standard clinical parameters.
