MyopiaNCT04275635
Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control
An observational study of Myopia, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Myopia
- What is being tested?
- Orthokeratology lenses
- Type of treatment
- Medical device
- How many people
- 3,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2020to Aug 2021
- Phase
- Observational
- 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 15 years
- All sexes
- Child
Study population: 3,000 children from Zhongshan Ophthalmic Center plan to wear orthokeratology lenses for myopia control.
Who may be able to join
- -6.0D≤SER≤-0.5D
- Astigmatism≤2.0D
Who cannot join
- Contraindications of wearing Ortho-K.
- Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
- Currently involved in other clinical studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center (Zhujiang New Town Branch), Sun Yat-sen University
Guangzhou, Guangdong, 510000
Yingfeng Zheng, M.D, Ph.D, +8613922286455, zhyfeng@mail.sysu.edu.cn
About this study
This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.
Read the detailed description
Orthokeratology (ortho-K) has been demonstrated to slow myopic progression and reduce axial elongation in young patients, but this treatment is limited by the need for contact lens wear, which is the common cause for keratitis in children, and therefore cautious use is recommended. There is a need to identify the patients that could benefit most from this treatment. In order to do so, we conduct a retrospective study and create a large database (n = 10,000) of de-identified data to train an algorithm for identifying fast progressing myopes. In addition, we will perform a prospective study to validate this predictive algorithm and determine the effectiveness of Orthokeratology among different individual patients in China.
- Conditions
- Myopia
- Being tested
- Orthokeratology lenses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orthokeratology lensesDevice
Orthokeratology lenses
| Study group | Role | What they receive |
|---|---|---|
| Children with myopia | A total of 3,000 children from Zhongshan Ophthalmic Center is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing Ortho-K. Receives: Device: Orthokeratology lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUROC of the prediction algorithm for identifying fast progressing myopes
Age-specific axial length (AL) changes previously described by Wang et al.(IOVS, 52 (11), 7949-53, 2011) are used as cut-off values to determine whether a child is a fast progressor or not. A child whose AL change falls on or above the cut-off value is considered to be a fast progressor.
Measured: 1 year
Secondary outcomes (3)
Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes
The investigators will estimate sensitivity and specificity of the predictive algorithm for identifying fast progressing myopes.
Measured: 1 year
Performance of an algorithm for predicting AL
The investigators will use mean absolute error (MAE), R square to evaluate the performance.
Measured: 1 year
Performance of an algorithm for predicting spherical equivalent refractive error
The investigators will use mean absolute error (MAE), R square to evaluate the performance.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start25 Feb 2020
- Primary completionMar 2021 (estimated)
- Study completionAug 2021 (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 MyopiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingfeng Zheng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275635
- Sponsor's protocol ID
- 2020KYPJ018
- Status last verified
- Mar 2020
- First submitted
- 17 Feb 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang D, Ding X, Liu B, Zhang J, He M. Longitudinal changes of axial length and height are associated and concomitant in children. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7949-53. doi: 10.1167/iovs.11-7684.
PubMed 21896861
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control
- ClinicalTrials.gov ID
- NCT04275635
- Acronym / sponsor ID
- 2020KYPJ018
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Feb 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 19 Feb 2020 (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.
This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.
Detailed description
Orthokeratology (ortho-K) has been demonstrated to slow myopic progression and reduce axial elongation in young patients, but this treatment is limited by the need for contact lens wear, which is the common cause for keratitis in children, and therefore cautious use is recommended. There is a need to identify the patients that could benefit most from this treatment. In order to do so, we conduct a retrospective study and create a large database (n = 10,000) of de-identified data to train an algorithm for identifying fast progressing myopes. In addition, we will perform a prospective study to validate this predictive algorithm and determine the effectiveness of Orthokeratology among different individual patients in China.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with myopia | – | Device: Orthokeratology lensesA total of 3,000 children from Zhongshan Ophthalmic Center is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing Ortho-K. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Age groups
- Child
- Study population
- 3,000 children from Zhongshan Ophthalmic Center plan to wear orthokeratology lenses for myopia control.
Key inclusion criteria (2 listed)
- -6.0D≤SER≤-0.5D
- Astigmatism≤2.0D
Key exclusion criteria (3 listed)
- Contraindications of wearing Ortho-K.
- Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
- Currently involved in other clinical studies.
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 |
|---|---|---|
| Orthokeratology lensesOrthokeratology lenses | Device | Children with myopia |
Primary outcome
AUROC of the prediction algorithm for identifying fast progressing myopes
Time frame: 1 year
Age-specific axial length (AL) changes previously described by Wang et al.(IOVS, 52 (11), 7949-53, 2011) are used as cut-off values to determine whether a child is a fast progressor or not. A child whose AL change falls on or above the cut-off value is considered to be a fast progressor.
3 secondary outcomes
Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes
Time frame: 1 year
Performance of an algorithm for predicting AL
Time frame: 1 year
Performance of an algorithm for predicting spherical equivalent refractive error
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
- Background: PubMed 21896861Wang D, Ding X, Liu B, Zhang J, He M. Longitudinal changes of axial length and height are associated and concomitant in children. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7949-53. doi: 10.1167/iovs.11-7684.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, 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 2 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 16 Mar 2020. 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 Yingfeng Zheng, M.D. Ph.D. (+8613922286455, zhyfeng@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUROC of the prediction algorithm for identifying fast progressing myopes (time frame: 1 year). 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 NCT04275635, 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 16 Mar 2020.