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| ID | Type | Description | Link |
|---|---|---|---|
| MR-33-22-012252 | Registry Identifier | Research Committee of China Medical Institute |
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| Name | Class |
|---|---|
| Ningbo Eye Hospital | OTHER |
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The goal of this clinical trial is to learn if 3 optical interventions(DIMS, DISC and orthokeratology) to control myopia have different efficacy to slow myopia progression in children when the control is single focus spectacles(SVS). It will also learn about the safety of all 4 interventions. The main questions it aims to answer are:
Does orthokeratology slows the progressing myopia more significant than the DIMS or DISK? What medical problems do participants have when taking orthokeratology, DIMS and DISK? Researchers will compare all the 3 interventions to a placebo (SVS) to see if 3 interventions has significant difference in slow the axial length elongation as well as the refraction changes.
Participants will:
Take orthokeratology, DIMS, DISK or SVS every day for 12 months Visit the clinic once every 3 months for checkups and tests.
orthokeratology and DISK are contact lenses, while DIMS and SVS are spectacles.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orthokeratology | Active Comparator | To wear Orthokeratology at night to slow down progressing myopia |
|
| defocus-incorporated multiple segment lenses (DIMS) spectacles | Experimental | To wear defocus-incorporated multiple segment lenses (DIMS) spectacles at daytime |
|
| defocus incorporated soft contact (DISK) lenses | Experimental | To wear defocus incorporated soft contact (DISK) lenses at daytime |
|
| single-vision spectacles (SVS) | Placebo Comparator | To wear SVS at daytime and at night before sleep |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthokeratology | Device | Orthokeratology is to a rigid contact lens with reverse design to flat the central cornea to correct the myopia, which is to use at night during sleep; DIMS and SVS are both spectacles to wear at daytime; DIMS has many tiny lenses at peripheral of the big lenses to make the peripheral retina myopic defocus during the daytime; SVS has only one focus while DIMS has many focuses made by the tiny segments lenses around the peripheral vision fields; DISK is a soft contact lens with peripheral myopic power design to make the myopic eyes defocus at peripheral during the daytime. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of axial length for 12-month (mm) | The ocular axial length change at follow-up of 12-month from baseline with IOLmaster 500(IOLMaster 500, Carl Zeiss Meditec AG, Germany) in the unit of millimetre | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Spherical Equivalence Refraction (D) | Changes of SER at 12-Month follow-up with cycloplegic refraction (Diopter, D) with the auto refractometer (Topcon KR-800, Topcon Corporation, Tokyo, Japan) | 12 months |
| Dropout rate (%) |
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Inclusion Criteria:
Must agree to participate in the study
Must have cycloplegic refraction with spherical equivalent refractive (SER)
Clinical diagnosis of astigmatism was ≤ 1.00D
Must be able to have corrected visual acuity ≤ 0.00 logMAR of either eye
Must be able to wear either of SVS/DIMS/DISC/Orthokeratology lenses and kept the same intervention for 12 month
Must have the front cornea curve value between 41.00D~44.00D
Must have axial length of the study eye between 23.00mm and 25.00mm at baseline
Exclusion Criteria:
All the genders are welcome to join the clinical trials. While those who is self-identified genders are eligible to participate while the record is not male or female.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ningbo Eye Hospital | Ningbo | Zhejiang | 315000 | China | ||
| Optometry department, Ningbo Eye Hospital |
The explanation why IPD will not be shared is that almost all the data to be obtained is on another clinic center with another external site. The data is confidential to obtain to outside system with complete details.
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D005139 | Eyeglasses |
| ID | Term |
|---|---|
| D007909 | Lenses |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
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| defocus-incorporated multiple segment lenses (DIMS) spectacles | Device | It is the special lenses with peripheral lots of tiny segments of plus lenses around the center |
|
| DISK | Device | SVS |
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| Single-focus spectacles | Device | Myopic Glasses with mono-focus in each eye |
|
The dropout rate of each group with the percentage (%) record by the formula =the dropout number versus total number of the each group *100%.
| 12 months |
| Changes of ocular axial length at follow-up of 3 months (mm) | Changes of ocular axial length at follow-up of 3 month from baseline with the IOLmaster 500(millimetre, mm) | 3 months |
| Changes of ocular axial length at follow-up of 6 months (mm) | Changes of ocular axial length at follow-up of 6 month from baseline with the IOLmaster 500(millimetre, mm) | 6 months |
| Changes of ocular axial length at follow-up of 9 months (mm) | Changes of ocular axial length at follow-up of 9 month from baseline with the IOLmaster 500(millimetre, mm) | 9 months |
| Ningbo |
| Zhejiang |
| 315000 |
| China |