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

ConditionMyopia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-8
SponsorShanghai Eye Disease Prevention and Treatment Center

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property
  • wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)
  • 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 , featuring photochromic properties with a light transmittance of 35% post-activation
  • wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property

Treatment groups

255 Participants
are divided into 5 treatment groups