Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control

Not Applicable

Recruiting

• Conditions: Myopia
• Interventions: Device: Ortho-k lenses; Drug: 0.01% Atropine

• Registration Number: NCT06667037
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

The purpose of this multicenter randomized clinical trial is to evaluate the myopia control effect of orthokeratology and 0.01% atropine sequential treatment in children and adolescents, as compared to continuous treatment with orthokeratology.

Detailed Description

Myopia constitutes a major threat to vision health globally for its increasing prevalence and irriversible blinding complications. It is crucial to effectively intervene subjects with progressive myopia to reduce risks of myopic pathologies in later life.

Orthokeratology (ortho-k) is the first-line intervention for myopia control, with an efficacy of slowing axial elongation by 43-63%. However, the efficacy decreases over time. Sequential treatment strategy, which switches myopia control interventions at some intervals, has a potential to increase myopia control efficacy regarding the whole treatment period, compared to applying one intervention throughout. However, there lacks evidence supporting the benefit of this treatment strategy.

The purpose of this study is to evaluate the effectiveness of orthokeratology and 0.01% atropine sequential treatment on myopia control in children and adolescents, as compared to continuous treatment with orthokeratology, using a multicenter randomized controlled trial design. Subjects will be randomly assigned into either ortho-k and 0.01% atropine sequential treatment group or ortho-k continuous treatment group. Their axial length will be monitored over two years. Changes in axial length in the two groups will be compared.

Study Timeline

• Study Start: 2024-09-21
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-29
• Study First Posted: 2024-10-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

1. Aged 8-15 years old.
2. Spherical equivalent refractions (SERs) -0.50 to -6.00 Dioptres (D) and astigmatism less than -1.5 D in both eyes, anisometropia less than 1.5 D.
3. Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes.
4. Bilateral intra-ocular pressure < 21mmHg.
5. Normal binocular and stereoscopic visual function.
6. Participants and their guardians' understanding and acceptance of random allocation of grouping.

Exclusion Criteria

1. Manifest strabismus, except for intermittent tropia.
2. Ocular or systemic diseases which may affect vision or refractive error.
3. Previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses.
4. Other contraindications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ortho-k and 0.01% atropine sequential treatment	Ortho-k lenses	Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year.
Ortho-k and 0.01% atropine sequential treatment	0.01% Atropine	Participants will be treated with ortho-k lenses during the first year, and swiched to recieve 0.01% atropine twice a day in the second year.
Ortho-k continuous treatment	Ortho-k lenses	Participants will be treated with ortho-k lenses throughout, during the 2-year study period.

Primary Outcome Measures

Name	Time	Method
Axial length change	From baseline to the end of treatment at 25 months	Axial length change (mm) is characterized as the difference between 25-month follow-up visit and baseline values. The IOLMaster or Lenstar are used to measure axial length (mm).

Secondary Outcome Measures

Name	Time	Method
Axial length change	From baseline to 3, 6, 9, 12, and 19 months.	Axial length change (mm) is characterized as the difference between 3, 6, 9, 12, and 19 months follow-up visit and baseline values. The IOLMaster or Lenstar are used to measure axial length (mm).
Proportion of rapid myopia progression	From baseline to the end of treatment at 25 months	Proportion of rapid myopia progression means the rate of cumulative axial growth ≥0.50 mm at 25 months) after intervention.
Incidence of adverse events	From baseline to 25 months.	Incidence of adverse events is the rate of adverse events over the study period for subjects in both arms.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China