MyopiaAVONCT05478356
The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control
A study testing low-dose atropine eye drops and orthokeratology in people with Myopia, run by Evidence Based Cataract Study Group at 2 sites in China.
Trial summary
Both orthokeratology and atropine eye drops are effective methods for myopia control, but few studies have compared them all together simultaneously. Therefore, the primary aim of the present study was to compare the effect of orthokeratology versus low-dose (0.01% and 0.02%) atropine on the control of myopia… Read more about this study
- Who is it for?
- Ages 8 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- low-dose atropine eye drops and orthokeratology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Best corrected visual acuity less then 0.00 log MAR (minimum angle of resolution) units Cycloplegic SER of - 1.0 D or less in both eyes. An inter-eye cycloplegic SER difference of 1.00 D or more.
Who cannot join
- Children with cycloplegic cylinder refraction of more than + 1.00 D or less than - 1.00 D.
- History of binocular vision problems, including strabismus. History of known ocular disorders, including media opacities, macular dysgenesis, optic nerve hypoplasia, perinatal brain injury, buphthalmos, and retinopathy of prematurity.
- History of medication use that might have affected the refractive results. Systemic or developmental problems that might have hindered refractive development.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Visionly Eye Hospital
Beijing, Beijing Municipality, 100038
Peng Zhou, M.D., 17898805125, drzhoupeng@gmail.com
- Recruiting
Parkway Hospital
Shanghai, Shanghai Municipality, 200001
Peng Zhou, M.D., 17898805125, drzhoupeng@gmail.com
About this study
Both orthokeratology and atropine eye drops are effective methods for myopia control, but few studies have compared them all together simultaneously. Therefore, the primary aim of the present study was to compare the effect of orthokeratology versus low-dose (0.01% and 0.02%) atropine on the control of myopia progression.
- Conditions
- Myopia
- Being tested
- low-dose atropine eye drops, orthokeratology
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-dose atropine eye dropsDrug
low-dose atropine eye drops
orthokeratologyDevice
orthokeratology, ortho-K lenses
| Study group | Role | What they receive |
|---|---|---|
| orthokeratology group | Experimental | Not described Receives: Device: orthokeratology |
| low-dose atropine group | Active comparator | Not described Receives: Drug: low-dose atropine eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of myopia
The change of myopia (Ds)
Measured: 1 year
Progression of axial length
The change of axial length (mm)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Evidence Based Cataract Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng ZHOU, Evidence Based Cataract Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478356
- Sponsor's protocol ID
- EvidenceBCSG
- Acronym
- AVO
- Status last verified
- Jul 2022
- First submitted
- 26 Jul 2022
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Low-dose Atropine and Orthokeratology in Pediatric Myopia Control
- ClinicalTrials.gov ID
- NCT05478356
- Acronym / sponsor ID
- AVO / EvidenceBCSG
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Evidence Based Cataract Study GroupUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 28 Jul 2022 (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.
Both orthokeratology and atropine eye drops are effective methods for myopia control, but few studies have compared them all together simultaneously. Therefore, the primary aim of the present study was to compare the effect of orthokeratology versus low-dose (0.01% and 0.02%) atropine on the control of myopia progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| orthokeratology group | Experimental | Device: orthokeratology |
| low-dose atropine group | Active comparator | Drug: low-dose atropine eye drops |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Best corrected visual acuity less then 0.00 log MAR (minimum angle of resolution) units Cycloplegic SER of - 1.0 D or less in both eyes. An inter-eye cycloplegic SER difference of 1.00 D or more.
Key exclusion criteria (3 listed)
- Children with cycloplegic cylinder refraction of more than + 1.00 D or less than - 1.00 D.
- History of binocular vision problems, including strabismus. History of known ocular disorders, including media opacities, macular dysgenesis, optic nerve hypoplasia, perinatal brain injury, buphthalmos, and retinopathy of prematurity.
- History of medication use that might have affected the refractive results. Systemic or developmental problems that might have hindered refractive development.
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 |
|---|---|---|
| low-dose atropine eye dropslow-dose atropine eye drops | Drug | low-dose atropine group |
| orthokeratologyorthokeratology, ortho-K lenses | Device | orthokeratology group |
Primary outcome
Progression of myopia
Time frame: 1 year
The change of myopia (Ds)
Progression of axial length
Time frame: 1 year
The change of axial length (mm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-dose atropine eye drops and orthokeratology in people with Myopia, run by Evidence Based Cataract Study Group at 2 sites 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Peng Zhou, M.D. (17898805125, drzhoupeng@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression of myopia (time frame: 1 year). The study lists 2 primary outcomes in all. 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 28 Jul 2022.