High MyopiaNCT04699357
The Effect and Safety of Different Doses of Atropine on Myopic Progression of Highly Myopic Children: Multi-centered Randomized Clinical Trial
A study testing Atropine in people with High Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 3 sites in China.
Trial summary
Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- High Myopia
- What is being tested?
- Atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 219 participants
- Where
- 3 sitesChina
- Study dates
- 4 Jul 2021to 1 Sep 2024
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- At least one eye with cycloplegic optometric spherical equivalent of -5.00 to -10.00D and best corrected distant visual acuity of at least 0.5 and near visual acuity of at least 1.0, Titmus Stereo acuity ≤ 80 seconds, Vision with external occultation of ≤ 10 prismatic diopters , vision with internal occultation of ≤ 6-8 prismatic diopters, and astigmatism equal to or less than -2.50D;
- Myopia progression greater than 0.5D in the past year;
- Possess normal cognitive and verbal communication abilities to actively cooperate with the prescribed treatment;
- Written informed consent from the guardian and the child.
Who cannot join
- Diseases of the study eye: keratitis, cone cornea, congenital cataract, glaucoma, fundus diseases; combined with inflammation of the anterior or posterior segment of the eye, such as acute conjunctivitis, iridocyclitis;
- Systemic diseases affecting the use of drugs: albinism, epilepsy, severe psychoneurological disorders, congenital heart disease, cardiac arrhythmias;
- Atropine allergy;
- Very low birth weight less than 1500 g;
- Previous treatment with anticholinergics including atropine within the previous 1 year, or use of OK lenses, multifocal soft lenses within 3 months;
- Other conditions judged by the investigator to be unsuitable for participation in the trial.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Shanghai General Hospital
Shanghai
Shanghai Ninth People's Hospital
Shanghai
About this study
Official title: Shanghai Eye Disease Prevention and Treatment Center
Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control.
Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.
- Conditions
- High Myopia
- Being tested
- Atropine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | 0.01% atropine Receives: Drug: Atropine |
| Group 2 | Experimental | 0.04% atropine Receives: Drug: Atropine |
| Group 3 | Experimental | 0.1% atropine Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of spherical equivalent
Spherical equivalent as measured by cycloplegia autorefraction
Measured: at least 2 years
Secondary outcomes (5)
Change in axial length
AL was measured as the distance from the anterior corneal surface to the retinal pigment epithelium (RPE) using IOLMaster or Lenstar
Measured: at least 2 years
Best corrected vision acuity (BCVA)
BCVA were measured at 4 meters by trained optometrists using the Early Treatment Diabetic Retinopathy Study (ETDRS) logMAR chart
Measured: at least 2 years
Intraocular pressure (IOP)
Intraocular pressure (IOP) is measured using a non-contact tonometer, with the average of three consecutive measurements taken.
Measured: at least 2 years
Pupil size
Photopic and mesopic pupil diameters were measured using a handheld device (VIP-300, NeurOptics) after a 2-minute light adaptation and a 5-minute dark adaptation, respectively
Measured: at least 2 years
Accommodative function
Positive/negative relative accommodation (PRA/NRA) were performed at a distance of 40 cm
Measured: at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start4 Jul 2021
- Primary completion21 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for High 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xun Xu, MD, Study director, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04699357
- Sponsor's protocol ID
- SHDC12019111
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2021
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Du L, Liu Z, Cheng T, Yan W, Ke B, Yuan Y, Li X, Zhou J, Chen J, Wang J, Pang CP, Zou H, Gao W, Xu X, He X. Different concentrations of atropine in children with high myopia: a 2-year multicenter double-blind, randomized controlled trial. Nat Commun. 2026 Oct 2;17(1):11282. doi: 10.1038/s41467-026-77797-2.
PubMed 42957683
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Eye Disease Prevention and Treatment Center
- ClinicalTrials.gov ID
- NCT04699357
- Acronym / sponsor ID
- SHDC12019111
- Conditions
- High Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 4 Jul 2021 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 7 Jan 2021 (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.
Objective: to evaluate the efficacy of different concentrations of atropine eye drops in controlling the progression (diopter, axial length) of high myopia in young children, and to compare the compliance, adverse reaction and regression rate of different concentrations of atropine eye drops in myopia control.
Intervention: Group 1 (0.01% atropine group), Group 2 (0.04% atropine group), Group 3 (0.1% atropine group). During the 2-year intervention period after entering the group, each concentration of atropine eye drops were given every night at a fixed time before going to bed, one drop each time, implemented by parents (supervision), and the wechat small program was completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: Atropine0.01% atropine |
| Group 2 | Experimental | Drug: Atropine0.04% atropine |
| Group 3 | Experimental | Drug: Atropine0.1% atropine |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- At least one eye with cycloplegic optometric spherical equivalent of -5.00 to -10.00D and best corrected distant visual acuity of at least 0.5 and near visual acuity of at least 1.0, Titmus Stereo acuity ≤ 80 seconds, Vision with external occultation of ≤ 10 prismatic diopters , vision with internal occultation of ≤ 6-8 prismatic diopters, and astigmatism equal to or less than -2.50D;
- Myopia progression greater than 0.5D in the past year;
- Possess normal cognitive and verbal communication abilities to actively cooperate with the prescribed treatment;
- Written informed consent from the guardian and the child.
Key exclusion criteria (6 listed)
- Diseases of the study eye: keratitis, cone cornea, congenital cataract, glaucoma, fundus diseases; combined with inflammation of the anterior or posterior segment of the eye, such as acute conjunctivitis, iridocyclitis;
- Systemic diseases affecting the use of drugs: albinism, epilepsy, severe psychoneurological disorders, congenital heart disease, cardiac arrhythmias;
- Atropine allergy;
- Very low birth weight less than 1500 g;
- Previous treatment with anticholinergics including atropine within the previous 1 year, or use of OK lenses, multifocal soft lenses within 3 months;
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 |
|---|---|---|
| Atropinedifferent concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children | Drug | Group 1, Group 2, Group 3 |
Primary outcome
Changes of spherical equivalent
Time frame: at least 2 years
Spherical equivalent as measured by cycloplegia autorefraction
5 secondary outcomes
Change in axial length
Time frame: at least 2 years
Best corrected vision acuity (BCVA)
Time frame: at least 2 years
Intraocular pressure (IOP)
Time frame: at least 2 years
Pupil size
Time frame: at least 2 years
Accommodative function
Time frame: at least 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Derived from this study: PubMed 42957683Du L, Liu Z, Cheng T, Yan W, Ke B, Yuan Y, Li X, Zhou J, Chen J, Wang J, Pang CP, Zou H, Gao W, Xu X, He X. Different concentrations of atropine in children with high myopia: a 2-year multicenter double-blind, randomized controlled trial. Nat Commun. 2026 Oct 2;17(1):11282. doi: 10.1038/s41467-026-77797-2.
- 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.
Xun Xu, MD study director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atropine in people with High Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 3 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes of spherical equivalent (time frame: at least 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04699357, which also lists 1 linked publication.
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 Mar 2026.