NCT06667037 Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control
| NCT ID | NCT06667037 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University |
| Condition | Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 194 participants |
| Start Date | 2024-09-21 |
| Primary Completion | 2026-12-31 |
Trial Parameters
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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.
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.