MyopiaNCT06667037
Orthokeratology and 0.01% Atropine Sequential Treatment for Myopia Control
A study testing Ortho-k lenses and 0.01% Atropine in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Myopia
- What is being tested?
- Ortho-k lenses and 0.01% Atropine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 8-15 years old.
- 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.
- Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes.
- Bilateral intra-ocular pressure < 21mmHg.
- Normal binocular and stereoscopic visual function.
- Participants and their guardians' understanding and acceptance of random allocation of grouping.
Who cannot join
- Manifest strabismus, except for intermittent tropia.
- Ocular or systemic diseases which may affect vision or refractive error.
- Previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses.
- Other contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center Sun Yat-Sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Myopia Control Effect of Orthokeratology and 0.01% Atropine Sequential Treatment in Children and Adolescents: A Multicenter Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- Ortho-k lenses, 0.01% Atropine
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ortho-k lensesDevice
Ortho-k lenses will be administered nightly.
0.01% AtropineDrug
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 group | Role | What they receive |
|---|---|---|
| Ortho-k and 0.01% atropine sequential treatment | Experimental | 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. Receives: Device: Ortho-k lenses; Drug: 0.01% Atropine |
| Ortho-k continuous treatment | Active comparator | Participants will be treated with ortho-k lenses throughout, during the 2-year study period. Receives: Device: Ortho-k lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to the end of treatment at 25 months
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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.
Measured: From baseline to 25 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start21 Sep 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Guangxi, Hunan Provincial People's Hospital, Tianjin Medical University Eye Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06667037
- Sponsor's protocol ID
- 2024KYPJ103
- Status last verified
- Aug 2026
- First submitted
- 14 Oct 2024
- Last updated
- 18 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopia Control Effect of Orthokeratology and 0.01% Atropine Sequential Treatment in Children and Adolescents: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06667037
- Acronym / sponsor ID
- 2024KYPJ103
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- People's Hospital of Guangxi, Hunan Provincial People's Hospital, Tianjin Medical University Eye Hospital
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ortho-k and 0.01% atropine sequential treatment | Experimental | Device: Ortho-k lenses, Drug: 0.01% AtropineParticipants 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 continuous treatment | Active comparator | Device: Ortho-k lensesParticipants will be treated with ortho-k lenses throughout, during the 2-year study period. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 8-15 years old.
- 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.
- Best corrected visual acuity (BCVA) equal to or better than 20/25 in both eyes.
- Bilateral intra-ocular pressure < 21mmHg.
- Normal binocular and stereoscopic visual function.
Key exclusion criteria (4 listed)
- Manifest strabismus, except for intermittent tropia.
- Ocular or systemic diseases which may affect vision or refractive error.
- Previous use of myopia control without washout, including atropine, myopia control spectacles, myopia control contact lenses.
- Other contraindications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ortho-k lensesOrtho-k lenses will be administered nightly. | Device | Ortho-k and 0.01% atropine sequential treatment, Ortho-k continuous treatment |
| 0.01% Atropine0.01% 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. | Drug | Ortho-k and 0.01% atropine sequential treatment |
Primary outcome
Axial length change
Time frame: 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).
3 secondary outcomes
Proportion of rapid myopia progression
Time frame: From baseline to the end of treatment at 25 months
Axial length change
Time frame: From baseline to 3, 6, 9, 12, and 19 months.
Incidence of adverse events
Time frame: From baseline to 25 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ortho-k lenses and 0.01% Atropine in people with Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length change (time frame: From baseline to the end of treatment at 25 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.