Eye--Refractive ErrorsNCT04005014
Effect of Using Myopia Prediction Algorithm
A study testing Myopia prediction algorithm in people with Eye--Refractive Errors, run by Sun Yat-sen University.
Trial summary
In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm. Read more about this study
- Who is it for?
- Ages 8 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Eye--Refractive Errors
- What is being tested?
- Myopia prediction algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,680 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2019to 31 Jan 2021
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children at Grade 3 (aged 8-9)
- Has the record of eye refraction examined in the past year
- Written informed consents provided
Who cannot join
- Definitive diagnosis of other ocular abnormalities except for refractive error
- Previous eye surgery
- Unwilling to participate in this trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Using Myopia Prediction Algorithm on Children's Eye Refraction in China: a Multi-center Randomized Control Trial
In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm.
Read the detailed description
We propose to enroll Grade 3 children from primary schools in China. Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development. The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups.
- Conditions
- Eye--Refractive Errors
- Being tested
- Myopia prediction algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myopia prediction algorithmOther
Candidate predictors included age at examination, SE, and annual progression rate. Using these predictors, the algorithm will be used to predict SE and whether patients will progress to high myopia in the subsequent 10 years.
| Study group | Role | What they receive |
|---|---|---|
| Using myopia prediction algorithm | Experimental | After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. Meanwhile, myopia prediction algorithm will be used to predict SE and presence of high myopia in the subsequent 10 years. Receives: Other: Myopia prediction algorithm |
| Not using myopia prediction algorithm | No intervention | After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SER development of at least -0.5 dioptres (D)
SER: sphere + ½ 360 cylinder; SER development of at least -0.5 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 1 year
Measured: Up to 1 year
Secondary outcomes (6)
Changes in SER \and AL
Changes in SER \and AL will be calculated; AL: axial length
Measured: Up to 1 year
Changes in proportion of children using atropine
Changes in proportion of children using atropine will be calculated
Measured: Up to 1 year
Changes in proportion of children using orthokeratology lenses
Changes in proportion of children using orthokeratology lenses will be calculated
Measured: Up to 1 year
Changes in proportion of children using spectacles
Changes in proportion of children using spectacles will be calculated
Measured: Up to 1 year
Changes in child's average outdoor activity time per day
Changes in child's average outdoor activity time per day will be calculated
Measured: Up to 1 year
Changes in child's average screen time per day
Changes in child's average screen time per day will be calculated
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start8 Jul 2019 (estimated)
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye--Refractive ErrorsStudies of the same condition, open and under way.
- More trials run by 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 1,680 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005014
- Sponsor's protocol ID
- CCPMOH2019-China-1
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 2 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Using Myopia Prediction Algorithm on Children's Eye Refraction in China: a Multi-center Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04005014
- Acronym / sponsor ID
- CCPMOH2019-China-1
- Conditions
- Eye--Refractive Errors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,680 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 8 Jul 2019 (estimated)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 2 Jul 2019 (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.
In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm.
Detailed description
We propose to enroll Grade 3 children from primary schools in China. Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development. The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Using myopia prediction algorithm | Experimental | Other: Myopia prediction algorithmAfter examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. Meanwhile, myopia prediction algorithm will be used to predict SE and presence of high myopia in the subsequent 10 years. |
| Not using myopia prediction algorithm | No intervention | –After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children. |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children at Grade 3 (aged 8-9)
- Has the record of eye refraction examined in the past year
- Written informed consents provided
Key exclusion criteria (3 listed)
- Definitive diagnosis of other ocular abnormalities except for refractive error
- Previous eye surgery
- Unwilling to participate in this trial
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 |
|---|---|---|
| Myopia prediction algorithmCandidate predictors included age at examination, SE, and annual progression rate. Using these predictors, the algorithm will be used to predict SE and whether patients will progress to high myopia in the subsequent 10 years. | Other | Using myopia prediction algorithm |
Primary outcome
Incidence of SER development of at least -0.5 dioptres (D)
Time frame: Up to 1 year
SER: sphere + ½ 360 cylinder; SER development of at least -0.5 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 1 year
6 secondary outcomes
Changes in SER \and AL
Time frame: Up to 1 year
Changes in proportion of children using atropine
Time frame: Up to 1 year
Changes in proportion of children using orthokeratology lenses
Time frame: Up to 1 year
Changes in proportion of children using spectacles
Time frame: Up to 1 year
Changes in child's average outdoor activity time per day
Time frame: Up to 1 year
Changes in child's average screen time per day
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
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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.
Haotian Lin principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing Myopia prediction algorithm in people with Eye--Refractive Errors, run by Sun Yat-sen University.
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 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 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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 Yahan Yang (+8615521013933, yah.yang39@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SER development of at least -0.5 dioptres (D) (time frame: Up to 1 year). 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 2 Jul 2019.