Clinical trial NCT06667037: Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control
Official title: Myopia Control Effect of Orthokeratology and 0.01% Atropine Sequential Treatment in Children and Adolescents: A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: People&#39;s Hospital of Guangxi
name: Henan Provincial People&#39;s Hospital
name: Tianjin Medical University Eye Hospital
First posted: 2024-10-31
Enrollment: 194
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Axial length change
timeFrame: From baseline to the end of treatment at 25 months
Secondary outcomes:
measure: Proportion of rapid myopia progression
timeFrame: From baseline to the end of treatment at 25 months
measure: Axial length change
timeFrame: From baseline to 3, 6, 9, 12, and 19 months.
measure: Incidence of adverse events
timeFrame: From baseline to 25 months.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center Sun Yat-Sen University
state: Guangdong
Study officials:
References: