Axial LengthCCESNCT05770661
China Children Eye Study
An observational study of Axial Length and Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 2 sites in China.
Trial summary
The primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents. 30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Axial Length, Myopia, Child Development
- How many people
- 30,000 participants
- Where
- 2 sitesChina
- Study dates
- 10 Mar 2023to 31 Dec 2026
- Phase
- Observational
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Students aged from 3 to 18 years old were recruited from schools to enroll the study.
Who may be able to join
- Aged 3 to 18 years
- Have been lived in the research areas for at least one year, and will not move to other places in the following two years
- Parents or guardians sign an informed consent form, and children over 6 years old need oral consent to participate
Who cannot join
- Mental diseases, unable to cooperate to complete the eye assessment
- Ophthalmic diseases, inability to cooperate to complete the inspection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Shanghai Eye Disease Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Xun Xu, MD, 86-13386259538, drxuxun@tom.com
- Recruiting
Shanghai Eye Disease Prevention and Treatment Center
Shanghai
Xiangui He, 8602153555032, xianhezi@163.com
About this study
Official title: China Nine Provinces Children Eye Study
The primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents.
30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits.
- Conditions
- Axial Length, Myopia, Child Development
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myopes | To collect the ocular data among myopic children. | |
| Non-myopes | To collect the ocular data among non-myopic children. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial length
Axial length in millimeter was examined by IOL Master
Measured: 2023-2026
Secondary outcomes (1)
Axial length elongation
The elongation in millimeter was the difference between two annual visits.
Measured: 2023-2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start10 Mar 2023
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial LengthStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Sichuan Provincial People's Hospital, Shandong University of Traditional Chinese Medicine, People's Hospital of Ningxia Hui Autonomous Region, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Guangxi Medical University, Affiliated Hospital of Inner Mongolia Minzu University, Xinjiang Hospital of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Jiannan Huang, Shanghai Eye Disease Prevention and Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770661
- Sponsor's protocol ID
- NO.CALS20220101
- Acronym
- CCES
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2023
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wu H, Wang Y, Ni Z, Liu Y, Liu Z, Chen J, Zou H, Morgan IG, Xu X, Rose KA, He X. HOTV Vision Test Compared With Tumbling E for Pediatric Vision Screening. JAMA Ophthalmol. 2026 Aug 27:e263425. doi: 10.1001/jamaophthalmol.2026.3425. Online ahead of print.
PubMed 42658504
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- China Nine Provinces Children Eye Study
- ClinicalTrials.gov ID
- NCT05770661
- Acronym / sponsor ID
- CCES / NO.CALS20220101
- Conditions
- Axial Length, Myopia, Child Development
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Tongji Hospital, Sichuan Provincial People's Hospital, Shandong University of Traditional Chinese Medicine, People's Hospital of Ningxia Hui Autonomous Region, First Affiliated Hospital of Kunming Medical University, First Affiliated Hospital of Guangxi Medical University, Affiliated Hospital of Inner Mongolia Minzu University, Xinjiang Hospital of Traditional Chinese Medicine
- Study start
- 10 Mar 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Mar 2023 (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 primary objective of this multi-center, observational study is to establish the reference ranges of axial length in Chinese children and adolescents.
30,000 children aged 3-18 years were examined with cycloplegia to collect their ocular parameters and were all followed up for three years with annual visits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myopes | – | –To collect the ocular data among myopic children. |
| Non-myopes | – | –To collect the ocular data among non-myopic children. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Students aged from 3 to 18 years old were recruited from schools to enroll the study.
Key inclusion criteria (3 listed)
- Aged 3 to 18 years
- Have been lived in the research areas for at least one year, and will not move to other places in the following two years
- Parents or guardians sign an informed consent form, and children over 6 years old need oral consent to participate
Key exclusion criteria (2 listed)
- Mental diseases, unable to cooperate to complete the eye assessment
- Ophthalmic diseases, inability to cooperate to complete the inspection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Axial length
Time frame: 2023-2026
Axial length in millimeter was examined by IOL Master
1 secondary outcome
Axial length elongation
Time frame: 2023-2026
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 7 Aug 2026.
- Derived from this study: PubMed 42658504Wu H, Wang Y, Ni Z, Liu Y, Liu Z, Chen J, Zou H, Morgan IG, Xu X, Rose KA, He X. HOTV Vision Test Compared With Tumbling E for Pediatric Vision Screening. JAMA Ophthalmol. 2026 Aug 27:e263425. doi: 10.1001/jamaophthalmol.2026.3425. Online ahead of print.
Related trials for Axial Length
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Axial Length and Myopia, run by Shanghai Eye Disease Prevention and Treatment Center 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 7 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 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?
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?
Contact Xun Xu, MD (021-53555032 ext. 86, drxuxun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial length (time frame: 2023-2026). 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 NCT05770661, 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 7 Aug 2026.