MyopiaPhase 4NCT05448989
Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia
A Phase 4 study testing 1% atropine 5+3 in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. 1% atropine ophthalmic drug has obvious curative effect for controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- 1% atropine 5+3
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to Dec 2024
- Phase
- Phase 4
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 6 to 12 years old;
- Both eyes are in line with the diagnosis of myopic refractive error and 0.25D < myopia spherical lens <4.00D after mydriasis, astigmatism <2.00D, binocular anisometropia <3.00D, and the best corrected distance vision is at least 0.8, myopia The force is at least 0.8;
- Visual function: Timus≤100 seconds, exophoria <5△, accommodation amplitude (AMP) ≥ age-related minimum accommodation amplitude value (minimum accommodation amplitude=15-0.25×age);
- No contraindications for atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.;
- The written informed consent of the guardian and the child himself.
Who cannot join
- History of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, fundus macular lesions or damage;
- Corneal curvature examination, the average K value of the anterior surface of the cornea is ≥45;
- Patients with ocular trauma, oblique or surgical eyes, atopic keratoconjunctivitis and other chronic eye diseases;
- Those with previous ophthalmia, severe angular, conjunctival infection and other eye diseases;
- Patients with neurological diseases and allergic or contraindications to atropine or other therapeutic drugs;
- Received other treatments to control the development of myopia in the past, such as the use of anticholinergic drugs such as atropine within 3 months, or participated in other relevant researchers such as functional frame mirrors and multifocal flexible mirrors;
- Other circumstances judged by the investigator to be unsuitable to participate in the research.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Diseases Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Haidong Zou, M.D., +86 13311986528, zouhaidong@sjtu.edu.cn
About this study
Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. 1% atropine ophthalmic drug has obvious curative effect for controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine "5+3" myopia control program and 1% atropine alternate eye myopia control program. Retrospective clinical research data showed that it could significantly reduce side effects and improve use compliance, but there is currently no evidence from prospective clinical studies.
Read the detailed description
Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. Among them, low-concentration atropine has few side effects and is the primary recommendation, but many clinical practices and studies suggest that its effect in controlling myopia is limited. 1% atropine ophthalmic drug has obvious curative effect advantages in controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine "5+3" myopia control (eye instillation for 5 consecutive nights in the first week of each month, one night per week in the 2nd, 3rd, and 4th weeks; after 3 months of monocular application, change to the contralateral eye), data from retrospective clinical studies have shown that it can significantly reduce side effects and improve compliance, but there is currently a lack of evidence from prospective clinical studies. Therefore, this study intends to use a randomized controlled trial, with 1% atropine used in both eyes once a week as the control group, to evaluate the effect of the "5+3" regimen in controlling myopia (spherical equivalent and axial length), safety (accommodation amplitude, amount of phoria, binocular vision function, etc.), and the compliance and side effects (photophobia, blurred vision, etc.).
- Conditions
- Myopia
- Being tested
- 1% atropine 5+3
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% atropine 5+3Drug
A method for myopia control using high-concentration atropine
| Study group | Role | What they receive |
|---|---|---|
| 1% atropine 5+3 | Experimental | Put the 1% atropine eye drops into the conjunctival sac, then close the eyes and press the nasolacrimal duct used for 5 consecutive nights in the first week of each month, one night per week in the 2nd, 3rd, and 4th weeks; after 3 months of monocular application, change to the contralateral eye Total treatment time 1 year Receives: Drug: 1% atropine 5+3 |
| 1% atropine weekly | Placebo comparator | Put the 1% atropine eye drops into the conjunctival sac, then close the eyes and press the nasolacrimal duct once a week in both eyes Total treatment time 1 year Receives: Drug: 1% atropine 5+3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Measured: Before atropine treatment
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Measured: 1months after treatment
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Measured: 3months after treatment
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Measured: 6months after treatment
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Measured: 9months after treatment
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Measured: 12months after treatment
axial length
axial length(AL), millimeter(mm), measured by IOL master
Measured: Before atropine treatment
axial length
axial length(AL), millimeter(mm), measured by IOL master
Measured: 1months after treatment
axial length
axial length(AL), millimeter(mm), measured by IOL master
Measured: 3months after treatment
axial length
axial length(AL), millimeter(mm), measured by IOL master
Measured: 6months after treatment
axial length
axial length(AL), millimeter(mm), measured by IOL master
Measured: 9months after treatment
axial length
axial length(AL), millimeter(mm), measured by IOL master
Measured: 12months after treatment
Secondary outcomes (33)
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Measured: Before atropine treatment
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Measured: 1months after treatment
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Measured: 3months after treatment
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Measured: 6months after treatment
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Measured: 9months after treatment
accommodation amplitude
Accommodation amplitude is measured by the amount of diopter change as the target is moved closer, diopter(D)
Measured: 12months after treatment
amount of phoria
measured by Von-Graefe method, degree(°)
Measured: Before atropine treatment
amount of phoria
measured by Von-Graefe method, degree(°)
Measured: 1months after treatment
amount of phoria
measured by Von-Graefe method, degree(°)
Measured: 3months after treatment
amount of phoria
measured by Von-Graefe method, degree(°)
Measured: 6months after treatment
amount of phoria
measured by Von-Graefe method, degree(°)
Measured: 9months after treatment
amount of phoria
measured by Von-Graefe method, degree(°)
Measured: 12months after treatment
binocular vision function
measured by Titmus method, second
Measured: Before atropine treatment
binocular vision function
measured by Titmus method, second
Measured: 1months after treatment
binocular vision function
measured by Titmus method, second
Measured: 3months after treatment
binocular vision function
measured by Titmus method, second
Measured: 6months after treatment
binocular vision function
measured by Titmus method, second
Measured: 9months after treatment
binocular vision function
measured by Titmus method, second
Measured: 12months after treatment
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Measured: 1months after treatment
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Measured: 3months after treatment
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Measured: 6months after treatment
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Measured: 9months after treatment
photophobia
the prevalence of photophobia known from Atropine Use and Adverse Reactions Questionnaire
Measured: 12months after treatment
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Measured: 1months after treatment
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Measured: 3months after treatment
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Measured: 6months after treatment
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Measured: 9months after treatment
blurred vision
the prevalence of blurred vision known from Atropine Use and Adverse Reactions Questionnaire
Measured: 12months after treatment
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Measured: 1months after treatment
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Measured: 3months after treatment
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Measured: 6months after treatment
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Measured: 9months after treatment
Other discomfort
Other discomfort reported by the patient but not included in the Atropine Use and Adverse Reactions Questionnaire
Measured: 12months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start1 Jan 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Xu, M.D., Study director, Shanghai Eye Diseases Prevention Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448989
- Sponsor's protocol ID
- 2021SQ001
- Status last verified
- Jul 2022
- First submitted
- 28 Jun 2022
- Last updated
- 12 Jul 2022
- 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia
- ClinicalTrials.gov ID
- NCT05448989
- Acronym / sponsor ID
- 2021SQ001
- Conditions
- Myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 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.
Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. 1% atropine ophthalmic drug has obvious curative effect for controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine "5+3" myopia control program and 1% atropine alternate eye myopia control program. Retrospective clinical research data showed that it could significantly reduce side effects and improve use compliance, but there is currently no evidence from prospective clinical studies.
Detailed description
Studies have shown that atropine eye drops are effective in controlling myopia in children and adolescents. Among them, low-concentration atropine has few side effects and is the primary recommendation, but many clinical practices and studies suggest that its effect in controlling myopia is limited. 1% atropine ophthalmic drug has obvious curative effect advantages in controlling myopia, but its side effects such as photophobia and blurred vision limit its popularization and use. In the early stage, our research group used 1% atropine "5+3" myopia control (eye instillation for 5 consecutive nights in the first week of each month, one night per week in the 2nd, 3rd, and 4th weeks; after 3 months of monocular application, change to the contralateral eye), data from retrospective clinical studies have shown that it can significantly reduce side effects and improve compliance, but there is currently a lack of evidence from prospective clinical studies. Therefore, this study intends to use a randomized controlled trial, with 1% atropine used in both eyes once a week as the control group, to evaluate the effect of the "5+3" regimen in controlling myopia (spherical equivalent and axial length), safety (accommodation amplitude, amount of phoria, binocular vision function, etc.), and the compliance and side effects (photophobia, blurred vision, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% atropine 5+3 | Experimental | Drug: 1% atropine 5+3Put the 1% atropine eye drops into the conjunctival sac, then close the eyes and press the nasolacrimal duct used for 5 consecutive nights in the first week of each month, one night per week in the 2nd, 3rd, and 4th weeks; after 3 months of monocular application, change to the contralateral eye Total treatment time 1 year |
| 1% atropine weekly | Placebo comparator | Drug: 1% atropine 5+3Put the 1% atropine eye drops into the conjunctival sac, then close the eyes and press the nasolacrimal duct once a week in both eyes Total treatment time 1 year |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 6 to 12 years old;
- Both eyes are in line with the diagnosis of myopic refractive error and 0.25D < myopia spherical lens <4.00D after mydriasis, astigmatism <2.00D, binocular anisometropia <3.00D, and the best corrected distance vision is at least 0.8, myopia The force is at least 0.8;
- Visual function: Timus≤100 seconds, exophoria <5△, accommodation amplitude (AMP) ≥ age-related minimum accommodation amplitude value (minimum accommodation amplitude=15-0.25×age);
- No contraindications for atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.;
- The written informed consent of the guardian and the child himself.
Key exclusion criteria (7 listed)
- History of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, fundus macular lesions or damage;
- Corneal curvature examination, the average K value of the anterior surface of the cornea is ≥45;
- Patients with ocular trauma, oblique or surgical eyes, atopic keratoconjunctivitis and other chronic eye diseases;
- Those with previous ophthalmia, severe angular, conjunctival infection and other eye diseases;
- Patients with neurological diseases and allergic or contraindications to atropine or other therapeutic drugs;
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 |
|---|---|---|
| 1% atropine 5+3A method for myopia control using high-concentration atropine | Drug | 1% atropine 5+3, 1% atropine weekly |
Primary outcome
spherical equivalent
Time frame: Before atropine treatment
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
spherical equivalent
Time frame: 1months after treatment
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
spherical equivalent
Time frame: 3months after treatment
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
spherical equivalent
Time frame: 6months after treatment
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
spherical equivalent
Time frame: 9months after treatment
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
spherical equivalent
Time frame: 12months after treatment
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
axial length
Time frame: Before atropine treatment
axial length(AL), millimeter(mm), measured by IOL master
axial length
Time frame: 1months after treatment
axial length(AL), millimeter(mm), measured by IOL master
axial length
Time frame: 3months after treatment
axial length(AL), millimeter(mm), measured by IOL master
axial length
Time frame: 6months after treatment
axial length(AL), millimeter(mm), measured by IOL master
axial length
Time frame: 9months after treatment
axial length(AL), millimeter(mm), measured by IOL master
axial length
Time frame: 12months after treatment
axial length(AL), millimeter(mm), measured by IOL master
33 secondary outcomes
accommodation amplitude
Time frame: Before atropine treatment
accommodation amplitude
Time frame: 1months after treatment
accommodation amplitude
Time frame: 3months after treatment
accommodation amplitude
Time frame: 6months after treatment
accommodation amplitude
Time frame: 9months after treatment
accommodation amplitude
Time frame: 12months after treatment
amount of phoria
Time frame: Before atropine treatment
amount of phoria
Time frame: 1months after treatment
amount of phoria
Time frame: 3months after treatment
amount of phoria
Time frame: 6months after treatment
amount of phoria
Time frame: 9months after treatment
amount of phoria
Time frame: 12months after treatment
binocular vision function
Time frame: Before atropine treatment
binocular vision function
Time frame: 1months after treatment
binocular vision function
Time frame: 3months after treatment
binocular vision function
Time frame: 6months after treatment
binocular vision function
Time frame: 9months after treatment
binocular vision function
Time frame: 12months after treatment
photophobia
Time frame: 1months after treatment
photophobia
Time frame: 3months after treatment
photophobia
Time frame: 6months after treatment
photophobia
Time frame: 9months after treatment
photophobia
Time frame: 12months after treatment
blurred vision
Time frame: 1months after treatment
blurred vision
Time frame: 3months after treatment
blurred vision
Time frame: 6months after treatment
blurred vision
Time frame: 9months after treatment
blurred vision
Time frame: 12months after treatment
Other discomfort
Time frame: 1months after treatment
Other discomfort
Time frame: 3months after treatment
Other discomfort
Time frame: 6months after treatment
Other discomfort
Time frame: 9months after treatment
Other discomfort
Time frame: 12months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- 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.
Yan Xu, M.D. study director
Shanghai Eye Diseases Prevention Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% atropine 5+3 in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center 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 5 inclusion and 7 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 12 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yan Xu, M.D. (+86 18621080996, drxuyan_2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
spherical equivalent (time frame: Before atropine treatment). The study lists 12 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 12 Jul 2022.