NCT07535658

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

Comparative Efficacy and Safety of Multi-Type Photolithography Flat Microstructure Spectacle Lenses Versus Spectacle Lenses With Aspherical Lenslets for Myopia Control in Chinese Children: A 12-Month Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 255 (estimated)
• Sponsor: Shanghai Eye Disease Prevention and Treatment Center · Academic / Other
• Sex: All
• Age: 6 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property	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.
DEVICE	wearing 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) for more than 8 hours.
DEVICE	wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 55% post-activation	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.
DEVICE	wearing Photolithography Plano Microstructure Lenses incorporates a multi-point defocus optical architecture , featuring photochromic properties with a light transmittance of 35% post-activation	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.
DEVICE	wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property	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

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2026-04-17
• Last updated: 2026-04-17

Locations

1 site across 1 country: China