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Clinical Trials in China / NCT06667037
Active, not recruiting Not applicable

Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control

NCT06667037 · tracked via the Priya Life Science China tracker
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
Phase
Not applicable
Started
2024-09-21
Last updated
2026-08-18

Condition(s) studied

Myopia

Investigational drug(s) / intervention(s)

Ortho-k lenses0.01% Atropine →

Ortho-k lenses: Ortho-k lenses will be administered nightly.

0.01% Atropine: 0.01% Atropine will be administrated twice a day with an interval of about 12 hours. Drop into the conjunctival sac and immediately compress the lacrimal sac of the inner canthus for 2-3 minutes.

Study 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

Sex
ALL
Min age
8 Years
Max age
15 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Ophthalmic Center Sun Yat-Sen University Guangzhou Guangdong

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Other trials for the same condition

A Study of the Efficacy and Safety of Two Low-concentration Atropine Sulfate Eye Drops Active, not recruiting
Auricular Acupressure Reduces Rebound Effects After Discontinuation of Atropine Starting soon
Spectacle Films Utilising S.T.O.P.® Technology for Slowing Down Myopia Progression in Children Active, not recruiting
Efficacy and Influencing Factors of Repeated Low-level Red-light in Myopia Active, not recruiting
Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06667037 on ClinicalTrials.gov ↗ ← All trials in China