Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control
NCT ID: NCT06667037
Last Updated: 2025-02-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
194 participants
INTERVENTIONAL
2024-09-21
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ortho-k and 0.01% atropine sequential treatment
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.
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.
Ortho-k continuous treatment
Participants will be treated with ortho-k lenses throughout, during the 2-year study period.
Ortho-k lenses
Ortho-k lenses will be administered nightly.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
8 Years
15 Years
ALL
No
Sponsors
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People's Hospital of Guangxi
UNKNOWN
Henan Provincial People's Hospital
UNKNOWN
Tianjin Medical University Eye Hospital
OTHER
Zhongshan Ophthalmic Center, Sun Yat-sen University
OTHER
Responsible Party
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Locations
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Zhongshan Ophthalmic Center Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024KYPJ103
Identifier Type: -
Identifier Source: org_study_id
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