Combined Orthokeratology and Low-Dose Atropine for Myopia Control in Children: A 12-Month Retrospective Clinical Study

Summary

This retrospective study evaluated orthokeratology combined with 0.01% atropine for controlling myopia progression in children over 12 months. Children receiving combination therapy showed lower axial elongation than those treated with orthokeratology alone, without serious ocular adverse events. The findings suggest additive benefits of low-dose atropine in pediatric myopia control.

Abstract

The increasing prevalence of childhood myopia and its association with vision-threatening complications have made myopia control a major public health concern. Orthokeratology lenses and low-dose atropine eye drops are commonly used interventions for slowing axial elongation in myopic children. This retrospective clinical study evaluated the effectiveness of combining orthokeratology lenses with 0.01% atropine eye drops over 12 months. Medical records of 60 children aged 8–12 years treated between June 2022 and December 2024 at Qichun County People’s Hospital, China, were reviewed. Thirty children received combination therapy, while 30 received orthokeratology alone. Baseline demographic and ocular biometric parameters were comparable between groups. Follow-up examinations were performed every 3 months and included cycloplegic refraction, axial length measurement, pupil diameter evaluation, and accommodative assessment. The primary outcome was 12-month axial elongation. Mean axial elongation was significantly lower in the combination group than in the Orthokeratology-only group (0.10 ± 0.14 mm vs 0.20 ± 0.15 mm; p = 0.01). Multivariate regression analysis showed that combination therapy was independently associated with reduced axial elongation (β = –0.10; 95% CI: –0.17 to –0.03; p = 0.02). The combination group showed a significant increase in pupil diameter during the first 4 months, while accommodative amplitude remained stable in both groups. No serious treatment-related adverse events were observed. These findings suggest that combining orthokeratology with low-dose atropine may provide additional benefit in slowing the progression of childhood myopia, although larger prospective studies are needed to confirm long-term efficacy and safety.

Introduction

Myopia has become one of the most prevalent ocular diseases globally, with the prevalence of myopia among children and adolescents on the rise. It is estimated that almost half of the world's population may suffer from myopia by 2050, and about 10% will develop high myopia. Myopia caused by progressive axial elongation is significantly associated with an increased risk of retinal detachment, glaucoma, myopic maculopathy, and other irreversible visual complications. As a result of this, preventing myopia progression in childhood has become an important public health issue, especially for children in East Asia who are at a particular risk of having a high prevalence of school-age myopia. Orthokeratology lenses and low-dose atropine eye drops are currently popular myopia control treatments due to their ability to slow down axial elongation. Orthokeratology is the temporary reshaping of the cornea with a special reverse-geometry rigid gas-permeable contact lens for a period of time to achieve clear daytime vision without the need for glasses. Perhaps more importantly, orthokeratology induces peripheral myopic defocus on the retina, which is thought to reduce the stimulus for excessive growth and axial elongation of the eyeball^1,2,3.

Low-dose (0.01%) atropine has also been effective in reducing progression with myopia without the side effects that are linked to the use of higher doses of atropine. While the exact mechanism(s) are not fully understood, atropine is believed to affect biochemical signaling pathways in the retina and sclera that regulate eye growth. Low-dose atropine has been shown to slow the rate of myopic development in clinical trial studies like the ATOM and LAMP with relatively mild side effects and minimal rebound after stopping the treatment^4,5,6.

Recent evidence suggests that orthokeratology, when combined with low-dose atropine, may have a synergistic effect in preventing axial elongation compared with either method alone. Combination therapy may have a beneficial effect by concurrently modulating both the optical peripheral defocus and the biochemical ocular-growth pathways. The data currently available, however, is limited by the heterogeneous study designs, sometimes inconsistent follow-up period, and different patient populations^7,8,9. In addition, there is limited real-world retrospective data on combination therapy in routine pediatric clinical practice. The present retrospective clinical study was thus designed to assess the relationship between orthokeratology and axial-length progression in myopic children during 12 months of treatment with orthokeratology and 0.01% atropine eye drops^10,11,12,13. The study also examined ocular changes and safety outcomes during treatment.

Orthokeratology lenses temporarily reshape the anterior surface of the cornea, allowing clear unaided vision during waking hours^{13,14,15,16,17}. More importantly, orthokeratology has been shown to significantly slow the progression of axial length elongation in myopic adolescents. The primary mechanism behind Orthokeratology’s myopia control lies in its ability to alter peripheral retinal defocus. Conventional spectacles correct central refractive error but often leave the peripheral retina in a hyperopic defocus, which may stimulate axial elongation¹⁸. Orthokeratology reshapes the central cornea and steepens the mid-peripheral zone, shifting peripheral retinal defocus toward myopic defocus, thereby reducing axial growth.

Multiple studies have demonstrated that orthokeratology can decrease axial elongation by 30–60% compared to single-vision spectacles. A landmark randomized trial by Cho and Cheung (ROMIO study) reported that children aged 6–10 who wore orthokeratology lenses experienced significantly less axial elongation over two years than controls^11,12,13. Meta-analyses confirm that orthokeratology lenses are effective with low-to-moderate myopia (typically -1.00 D to -6.00 D), with some benefit extending to higher myopic ranges⁹. Efficacy is most pronounced in the first year of wear and may decline over time, potentially due to adaptation or physiological compensation.

Several previous studies and meta-analyses have suggested that orthokeratology combined with low-dose atropine may reduce axial elongation more effectively than orthokeratology alone. Prospective clinical studies have reported lower annual axial growth rates in children receiving combination therapy, and pooled analyses have demonstrated favorable treatment effects with acceptable short-term safety profiles^15,16. However, the currently available evidence remains limited by heterogeneous study designs, relatively small sample sizes, varying follow-up durations, and differences in patient populations. In addition, there is comparatively limited retrospective real-world clinical data evaluating combination therapy in routine pediatric ophthalmology practice.

Therefore, the present retrospective clinical study was conducted to evaluate the effectiveness and safety of orthokeratology combined with 0.01% atropine eye drops in children with myopia over a 12-month follow-up period. The study primarily aimed to compare axial length progression between children receiving combination therapy and those treated with orthokeratology alone, while also assessing pupil diameter changes, accommodative function, and treatment-related adverse events.

Protocol

This retrospective study was approved by the Ethics Committee of Qichun County People’s Hospital, Hubei Province, China (Approval No.: 2025-KY-031). The study adhered to the principles of the Declaration of Helsinki. Because anonymized retrospective clinical records were analyzed and no additional interventions were performed, the ethics committee waived the requirement for written informed consent and child assent.

1. Study design and participant selection

NOTE: In the present study, pediatric myopia records from the Ophthalmology Department of Qichun County People’s Hospital, Hubei Province, China, between June 2022 and December 2024 were retrospectively reviewed and collected.

1. Identify sequential medical records of children aged 8–12 years treated with orthokeratology alone or as part of a combined therapy with 0.01% atropine eye drops for at least 12 months.
2. Recruit children with baseline SE between –1.00 d and –4.00 d and baseline < –1.50 d of astigmatism and have complete baseline and follow-up data at 12 months.
3. Remove records of children who have already been treated for myopia and whose previous treatment was not compliant; exclude those with ocular disease, corneal pathology, systemic disease that affects eye development, poor orthokeratology compliance, poor follow-up, or missing biometric data.
4. Only use right eye data in the main analysis to avoid eye correlation problems. If the right eye does not meet the criteria, then examine the left eye.

2. Baseline ophthalmic examination

1. Use a standard log visual acuity chart to measure unaided and best corrected visual acuity. After giving two doses of 1% cyclopentolate hydrochloride at an interval of 5 min, perform cycloplegic autorefraction.
2. Take refractive measurements 30 min after the last cycloplegic drop. Avoid wearing orthokeratology lenses for at least 7 consecutive nights prior to cycloplegic refraction to minimize the effects of the reshaping of the cornea on refractive assessment.
3. Measure axial length with an optical biometer. Take 5 readings and calculate the mean for analysis.
4. Use a calibrated digital pupillometer to measure the pupil diameter in a controlled room light setting. Measure the amplitude of accommodation by the push-up method.

3. Orthokeratology lens fitting

1. Perform corneal topography using a computerized corneal topographer.
2. Obtain at least three high-quality corneal topography scans before lens fitting. Fit reverse-geometry rigid gas-permeable orthokeratology lenses according to manufacturer guidelines.
3. Evaluate lens centration, movement, and fluorescein fitting patterns under slit-lamp examination. Confirm adequate central alignment, mid-peripheral bearing, and peripheral tear exchange before final lens dispensing.
4. Instruct children to wear the lenses overnight for approximately 7–8 h and remove the lenses immediately after waking.

4. Lens cleaning and disinfection

1. Make sure children and guardians wash and dry their hands before handling the lenses. Show how to insert, remove, clean, and rinse a lens and how to store it.
2. Use a surfactant cleaner to clean lenses every day, and a hydrogen peroxide lens-care system to disinfect lenses. Clean and then store lenses in a sterile disinfecting solution.
3. To reduce the risk of microbial contamination of the lens, avoid getting it wet when handling it.

5. Atropine administration

1. Place one drop of the 0.01 % atropine ophthalmic solution into each eye every evening before wearing orthokeratology lenses, in the combination group.
2. For storage pre-use, keep atropine solution in a sterile container at 4 °C. Advise guardians not to come in contact with the ocular surface while giving the medication.
3. Document photophobia, eye symptoms, eye redness, or other negative effects at follow-up visits.

6. Follow-up examinations

1. Perform follow-up examinations every 3 months for 12 months. Evaluate lens centration, corneal integrity, treatment adherence, and lens hygiene during each visit.
2. Measure axial length, pupil diameter, and accommodative amplitude during follow-up visits using the same instruments and illumination settings as baseline examinations. Perform cycloplegic autorefraction using the same cycloplegia protocol.
3. Inspect the cornea using a slit-lamp biomicroscope to identify corneal staining, infiltrates, epithelial defects, or signs of infection.

7. Outcome measures

NOTE: The main outcome of interest is total axial-length change over 12 months.

1. Subtract baseline axial length from measured axial lengths at each follow-up interval to calculate axial elongation.
2. Identify secondary outcomes as interval change in axial length, interval change in spherical equivalent refraction, interval change in pupil diameter, interval change in accommodative amplitude, and treatment-related adverse events.

8. Statistical analysis

1. Analyze data statistically by SPSS software. Report continuous variables using the mean ± SD and categorical variables using frequencies and percentages.
2. Use an independent-sample t-test or chi-square test to compare baseline characteristics among groups as appropriate. Perform repeated measures ANOVA to analyze changes over time in biological variables.
3. Use multivariate linear regression analysis to assess independent predictors of axial elongation at baseline spherical equivalent refraction and treatment group as covariates. Take p-values < 0.05 to be significant.

Results

The records of children with myopia were reviewed, and 74 children who met the inclusion criteria were identified from June 2022 to December 2024. Fourteen records were excluded due to incomplete follow-up data (n = 6), previous myopia control treatment (n = 4), poor orthokeratology compliance (n = 2), and incomplete biometric data (n = 2). A final group of 60 children met the eligibility criteria and was included in the analysis (Figure 1).

Of the 60 children inc...

Discussion

The global rise in myopia, particularly among children, has appeared as an important concern in public health and clinical ophthalmology. Predictions estimate that by 2050, nearly half of the global population will be myopic, with up to 10% developing high myopia^5,6,7. This trend carries profound implications due to the associated risk of irreversible vision-threatening complications such as retinal detachment, glaucoma, choroid...

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Atropine Sulfate Eye Drops (0.01%)	Xingqi Pharmaceutical Co., Ltd. (China)	National Drug Approval No. H20083192	Low-dose atropine administered once nightly in both eyes in the combination therapy group
Autorefractor	Topcon Corporation (China)	KR-800	Used to measure cycloplegic spherical equivalent refraction
Computerized corneal topographer	Medmont International Pty Ltd., Australia	Medmont E300	Used to obtain corneal topography before orthokeratology lens fitting
Cyclopentolate Hydrochloride Eye Drops (1%)	Santen Pharmaceutical (China) Co., Ltd.	National Drug Approval No. H20065938	Two drops instilled 5 min apart to induce cycloplegia prior to refraction
Fluorescein Sodium Strips	Jingming New Technology Development Co., Ltd. (China)	JM-FS01	Used for fluorescein staining during orthokeratology lens fitting
Optical Biometer	Carl Zeiss Meditec (China)	IOLMaster 700	Used to measure axial length; five consecutive readings averaged per eye
Orthokeratology (OK) Lenses	Euclid Systems Corporation (China)	Euclid OK Lens VST	Overnight rigid gas-permeable orthokeratology lenses customized according to corneal topography and baseline refraction
Slit-Lamp Biomicroscope	Kanghua Ruiming Medical Instrument Co., Ltd. (China)	KHB-SLM-3	Used for anterior segment examination and evaluation of lens centration
Statistical Analysis Software	IBM Corp.	SPSS Statistics Version 26.0	Used for statistical analyses including t-tests, ANOVA, and repeated-measures analysis