Using orthokeratology and atropine to control myopia in children

Myopia Control Effect of Orthokeratology and 0.01% Atropine Sequential Treatment in Children and Adolescents: A Multicenter Randomized Controlled Trial

This study is testing if using a combination of special contact lenses and a low-dose eye drop can help control worsening nearsightedness in children and teens aged 8 to 15 better than just using the contact lenses alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 194 (estimated)
• Ages: 8 Years to 15 Years
• Sex: All
• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Academic / other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06667037 on ClinicalTrials.gov

What this trial studies

This multicenter randomized clinical trial aims to evaluate the effectiveness of a sequential treatment approach combining orthokeratology and 0.01% atropine for controlling myopia in children and adolescents. Participants aged 8-15 years will be randomly assigned to either the sequential treatment group or a continuous orthokeratology treatment group. The study will monitor changes in axial length over two years to assess the efficacy of the sequential treatment strategy compared to continuous treatment. This approach seeks to enhance myopia control by alternating interventions, addressing the decreasing efficacy of single treatments over time.

Who should consider this trial

Good fit: Ideal candidates are children and adolescents aged 8-15 years with specific refractive error criteria.

Not a fit: Patients with previous myopia control treatments or certain ocular/systemic diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve myopia control in children, potentially reducing the risk of severe vision complications later in life.

How similar studies have performed: While orthokeratology is a well-established treatment, the sequential approach with atropine is relatively novel and lacks extensive prior evidence.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Zhongshan Ophthalmic Center Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Yin Hu, Doctor

Conditions Myopia