Refractive ErrorsNCT04044755
Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children
A study testing Myopia prediction algorithm in people with Refractive Errors, run by Sun Yat-sen University at 1 site in China.
Trial summary
In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Refractive Errors
- What is being tested?
- Myopia prediction algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,138 participants
- Where
- 1 siteChina
- Study dates
- 3 Aug 2019to 30 Nov 2020
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 8-10
- Has the record of eye refraction examined in the past year, SER<-0.5D
- Current BCVA≥0.8, SER<-0.5D, Astigmatism less than 1.50 D, anisometropia less than 1.50 D
- Written informed consents provided
Who cannot join
- Definitive diagnosis of other diseases except for refractive error
- Previous eye surgery
- Previous usage of orthokeratology lenses and atropine
- Unwilling to participate in this trial
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Centre
Guangzhou, Guangdong, 510623
Yahan Yang, +86-15521013933
About this study
Official title: Investigating the Effect of Using Myopia Prediction Algorithm on Myopia 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 myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm
Read the detailed description
We propose to enroll myopia children aged 8-10 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
- Refractive Errors
- Being tested
- Myopia prediction algorithm
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myopia prediction algorithmOther
Candidate predictors mainly includes age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 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 SER at 3 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: spherical equivalent refraction, 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 (13)
Incidence of SER development of at least -1.0 dioptres (D)
SER: spherical equivalent refraction, sphere + ½ 360 cylinder; SER development of at least -1.0 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 2 year
Measured: Up to 2 year
Changes in SER \ and AL
Changes in SER \ and AL will be calculated; AL: axial length
Measured: Up to 1 year
Changes in SER \ and AL
Changes in SER \ and AL will be calculated; AL: axial length
Measured: Up to 2 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 atropine
Changes in proportion of children using atropine will be calculated
Measured: Up to 2 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 orthokeratology lenses
Changes in proportion of children using orthokeratology lenses will be calculated
Measured: Up to 2 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 proportion of children using spectacles
Changes in proportion of children using spectacles will be calculated
Measured: Up to 2 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 outdoor activity time per day
Changes in child's average outdoor activity time per day will be calculated
Measured: Up to 2 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
Changes in child's average screen time per day
Changes in child's average screen time per day will be calculated
Measured: Up to 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start3 Aug 2019
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 2,138 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
- NCT04044755
- Sponsor's protocol ID
- CCPMOH2019-China-3
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 7 Aug 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 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effect of Using Myopia Prediction Algorithm on Myopia Children's Eye Refraction in China: a Multi-center Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04044755
- Acronym / sponsor ID
- CCPMOH2019-China-3
- Conditions
- Refractive Errors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,138 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 3 Aug 2019 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 5 Aug 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 myopia children using myopia prediction algorithm and myopia children without using myopia prediction algorithm
Detailed description
We propose to enroll myopia children aged 8-10 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
- Single blind (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 SER at 3 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 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 8-10
- Has the record of eye refraction examined in the past year, SER<-0.5D
- Current BCVA≥0.8, SER<-0.5D, Astigmatism less than 1.50 D, anisometropia less than 1.50 D
- Written informed consents provided
Key exclusion criteria (4 listed)
- Definitive diagnosis of other diseases except for refractive error
- Previous eye surgery
- Previous usage of orthokeratology lenses and atropine
- 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 mainly includes age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 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: spherical equivalent refraction, 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
13 secondary outcomes
Incidence of SER development of at least -1.0 dioptres (D)
Time frame: Up to 2 year
Changes in SER \ and AL
Time frame: Up to 1 year
Changes in SER \ and AL
Time frame: Up to 2 year
Changes in proportion of children using atropine
Time frame: Up to 1 year
Changes in proportion of children using atropine
Time frame: Up to 2 year
Changes in proportion of children using orthokeratology lenses
Time frame: Up to 1 year
Changes in proportion of children using orthokeratology lenses
Time frame: Up to 2 year
Changes in proportion of children using spectacles
Time frame: Up to 1 year
Changes in proportion of children using spectacles
Time frame: Up to 2 year
Changes in child's average outdoor activity time per day
Time frame: Up to 1 year
Changes in child's average outdoor activity time per day
Time frame: Up to 2 year
Changes in child's average screen time per day
Time frame: Up to 1 year
Changes in child's average screen time per day
Time frame: Up to 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myopia prediction algorithm in people with Refractive Errors, run by Sun Yat-sen University 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 4 inclusion and 4 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 7 Aug 2019. 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. 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 7 Aug 2019.