Efficacy and Safety of Specialty-Designed Orthokeratology Lenses with a Reduced Corneal Central Zone Moulding Area in Children with Low Myopia: A Prospective, Randomised, Controlled Trial
In brief
Specialty orthokeratology lenses cut eye growth by about half in children
In an 80-child randomized trial, axial elongation over 12 months was 0.077 mm with specialty-designed lenses versus 0.168 mm with standard lenses - about 54% less growth. Severe adverse events did not differ significantly between groups, but the trial was small and lasted only a year, so longer-term effects and safety remain uncertain.
- Journal
- Ophthalmic & physiological optics : the journal of the British College of Ophthalmic Opticians (Optometrists) (Q1)
- Published
- 6 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Qi Zhang, Changliang Peng, Yishu Wang, Chen Chu, Tao Yu, Jianfeng Zhu
- PMID
- 42839112
- DOI
- 10.1007/s44402-026-00194-1
Why clinicians should know about it
- Picked for Ophthalmology (top studies of the week, 11 October 2026): Specialty ortho‑k lenses reduce axial elongation in low myopia
Abstract
PURPOSE: Orthokeratology (ortho-k) is widely used for myopia control in children. Specialty-designed ortho-k lenses with a modified corneal reshaping profile may offer an alternative approach for myopia control through altered lens design characteristics. This study aimed to evaluate the efficacy and safety of this lens design in slowing axial elongation and myopia progression in children with low myopia, and to explore ocular structural predictors of the treatment response. METHODS: This prospective, randomised, double-masked clinical trial enroled 80 children aged 8-14 years with low myopia (-1.00 to -3.00 D). Participants were randomly assigned (1:1) to wear either standard-design ortho-k lenses or specialty-designed ortho-k lenses designed to produce a reduced corneal central zone moulding area for 12 months. Axial length was measured at baseline and at 1, 3, 6, 9 and 12 months. The primary outcome was the change in axial length (ΔAL) over time. Secondary outcomes included changes in spherical equivalent refraction (SER) and adverse events. RESULTS: The mean base curve squared (BC2), representing the estimated corneal central zone moulding area, was 8.73 ± 5.59 mm2 in the test group, which was significantly smaller than that in the control group (11.21 ± 5.17 mm2; t = 2.685, p = 0.008). Compared with the control group, the values of ΔAL at month 6 (0.103 ± 0.14 vs. 0.047 ± 0.11, p = 0.01), month 9 (0.141 ± 0.16 vs. 0.060 ± 0.12, p = 0.002) and month 12 (0.168 ± 0.20 vs. 0.077 ± 0.14, p = 0.004) were significantly smaller. No significant difference in severe adverse events was observed between the two groups. CONCLUSION: Orthokeratology effectively slowed axial elongation in children with low myopia. Specialty-designed ortho-k lenses with altered corneal reshaping characteristics demonstrated greater inhibition of axial elongation. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2500113706, retrospectively registered on 2 December 2025.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.