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The goal of this clinical trial is to learn if photolithographic flat microstructure lenses work to prevent myopia in children. It will also learn about the safety of different designs of photolithographic flat microstructure lenses. The main questions it aims to answer are:
Are photolithography flat microstructure lenses effective and safe in preventing myopia in children? Does the depth of tinted lenses affect visual quality? Researchers will compare photolithography flat microstructure lenses to a spectacle lenses with aspherical lenslets to see if photolithography flat microstructure lenses works to prevent myopia in children.
Participants will:
Wear photolithography flat microstructure lenses or Spectacle Lenses with Aspherical Lenslets more than 8H per day for 1 year.
Visit the clinic once every 3 months for checkups and tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PPML(multi-point defocus design, non-fading, Nuo Tong) | Experimental | The group wears photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property. |
|
| PPML (multi-point defocus design, color, light transmittance 55% after photochromism, Nuo Tong) | Experimental | PPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation. |
|
| PPML (multi-point defocus design, color, light transmittance 35% after photochromism, Nuo Tong) | Experimental | PPML (Photolithography Plano Microstructure Lenses) incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation. |
|
| PPML (designed to reduce contrast, non-fading, Nuo Tong) | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property | Device | wearing photolithography plano microstructure lenses （PPML） with a multi-point defocus design, manufactured by Nuo Tong, which feature a non-fading optical property for more than 8 hours a day. |
| Measure | Description | Time Frame |
|---|---|---|
| Use 1% cyclopentolate hydrochloride eye drops (Cyclogyl) for cycloplegia and compare the difference in Sphere equivalent refractive changes over 12 months. | Computerized refractometer testing, The formula for calculating sphere equivalent power: sphere power + 0.5 * cylinder power | From enrollment to the end of treatment at 12 month |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in 12-month axial length (AL, mm) from baseline | Measure the length of the eye axis using the IOL Master 700 and compare the difference in eye axis length over 12 months. | From enrollment to the end of treatment at 12 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiurong Lin | Contact | +8615216698330 | LQRoph@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Eye Disease Prevention and treatment Center | Shanghai | 200336 | China |
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PPML (Photolithography Plano Microstructure Lenses), designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property
|
| Plano microstructure lenses (multi-point defocus design，Aspherical Lenslets, Essilor Stellest) | Active Comparator | Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) |
|
|
| wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) | Device | wearing plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest) for more than 8 hours. |
|
| wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation | Device | Wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 55% post-activation for more than 8 hours. |
|
| wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activation | Device | Wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture manufactured by Nuo Tong, featuring photochromic properties with a light transmittance of 35% post-activation for more than 8 hours. |
|
| wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property | Device | wearing Photolithography Plano Microstructure Lenses designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property for more than 8 hours |
|
| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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