Efficacy of Multi-Type Photolithography Flat Microstructure Lenses for Childhood Myopia Control

Sponsor
Shanghai Eye Disease Prevention and Treatment Center
Study ID
NCT07535658
Status
Not Yet Recruiting

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Conditions

  • Myopia

Eligibility Criteria

Sex
ALL
Age
6 Years - 8 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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

Study Details

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.

Key Dates

First listed
Apr 17, 2026
Start date
Apr 15, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
255 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: PPML(multi-point defocus design, non-fading, Nuo Tong)
    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.
  • Experimental: PPML (multi-point defocus design, color, light transmittance 55% after photochromism, Nuo Tong)
    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.
  • Experimental: PPML (multi-point defocus design, color, light transmittance 35% after photochromism, Nuo Tong)
    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.
  • Experimental: PPML (designed to reduce contrast, non-fading, Nuo Tong)
    PPML (Photolithography Plano Microstructure Lenses), designed by Nuo Tong to reduce contrast sensitivity and featuring a non-fading optical property
  • Active Comparator: Plano microstructure lenses (multi-point defocus design，Aspherical Lenslets, Essilor Stellest)
    Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)

Primary Outcome Measure

Use 1% cyclopentolate hydrochloride eye drops (Cyclogyl) for cycloplegia and compare the difference in Sphere equivalent refractive changes over 12 months. [ Time Frame: From enrollment to the end of treatment at 12 month ]

Central Contacts

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