Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control
Study Details
Study Description
Brief Summary
This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: Orthokeratology lenses
Orthokeratology lenses
|
Outcome Measures
Primary Outcome Measures
- AUROC of the prediction algorithm for identifying fast progressing myopes [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.
Secondary Outcome Measures
- Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes [1 year]
The investigators will estimate sensitivity and specificity of the predictive algorithm for identifying fast progressing myopes.
- Performance of an algorithm for predicting AL [1 year]
The investigators will use mean absolute error (MAE), R square to evaluate the performance.
- Performance of an algorithm for predicting spherical equivalent refractive error [1 year]
The investigators will use mean absolute error (MAE), R square to evaluate the performance.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
-6.0D≤SER≤-0.5D
-
Astigmatism≤2.0D
Exclusion Criteria:
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zhognshan Ophthalmic Center (Zhujiang New Town Branch), Sun Yat-sen University | Guangzhou | Guangdong | China | 510000 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 2020KYPJ018