An interventional study of Ortho-k lenses and 0.01% Atropine in Myopia, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 8 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Treatment
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.
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 112 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 159 studies on the registry; 77 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Ortho-k lenses · Drug: 0.01% Atropine
Participants will be treated with ortho-k lenses throughout, during the 2-year study period.
Device: Ortho-k lenses
Ortho-k lenses will be administered nightly.
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.
Axial length change
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).
Time frame: From baseline to the end of treatment at 25 months
Proportion of rapid myopia progression
Proportion of rapid myopia progression means the rate of cumulative axial growth ≥0.50 mm at 25 months) after intervention.
Time frame: From baseline to the end of treatment at 25 months
Axial length change
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).
Time frame: From baseline to 3, 6, 9, 12, and 19 months.
Incidence of adverse events
Incidence of adverse events is the rate of adverse events over the study period for subjects in both arms.
Time frame: From baseline to 25 months.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Zhongshan Ophthalmic Center, Sun Yat-sen University