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.
Age: 6 years ≤ age ≤ 8 years (calculated based on the informed consent date);
The spherical equivalent (SE) of both eyes is 0D to +1.00D (inclusive of boundary values) after cycloplegia;
Astigmatism: Cylindrical power of both eyes ≤ 1.00D;
Anisometropia: Difference in spherical equivalent between both eyes ≤ 1.00D;
History or presence of glaucoma, corneal disease, or other ocular organic disease, or acute or chronic ocular inflammation;
Combined with systemic major diseases, mental diseases, or systemic collagen metabolism diseases;
Used any myopia intervention drugs or devices in the past 3 months;
Those who have participated in other similar clinical studies in the past 3 months;
Parallel
wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property
Devicewearing 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.
wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)
Devicewearing 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
DeviceWearing 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
DeviceWearing 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
Devicewearing Photolithography Plano Microstructure Lenses designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property for more than 8 hours
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
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.
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This trial is not recruiting at the moment. You can still explore other options:
