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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia
• Intervention / Treatment: Device: wearing photolithography plano microstructure lenses with multi-point defocus design, non-fading optical property; Device: 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 , featuring photochromic properties with a light transmittance of 35% post-activation; Device: wearing Photolithography Plano Microstructure Lenses designed to reduce contrast sensitivity and featuring a non-fading optical property; Device: wearing Plano microstructure lenses featuring multi-point defocus design with aspherical lenslets (Essilor Stellest)

• Study Type: Interventional
• Enrollment (Estimated): 255
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qiurong Lin; Phone Number: +8615216698330; Email: LQRoph@163.com

Study Locations

• China
  • Shanghai, China, 200336
    • Shanghai Eye Disease Prevention and Treatment Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age: 6 years ≤ age ≤ 8 years (calculated based on the informed consent date);
2. The spherical equivalent (SE) of both eyes is 0D to +1.00D (inclusive of boundary values) after cycloplegia;
3. Astigmatism: Cylindrical power of both eyes ≤ 1.00D;
4. Anisometropia: Difference in spherical equivalent between both eyes ≤ 1.00D;
5. Corrected visual acuity: Best corrected visual acuity (BCVA) of both eyes ≥ 1.0 (decimal notation, 5m);
6. General health status: No systemic syndromes that affect ocular development; no long-term use of growth hormone, corticosteroids, or antiepileptic drugs;
7. Previous intervention: No use of any myopia control methods within the past 3 months, including but not limited to: multifocal glasses, atropine eye drops, red light therapy, acupuncture, etc.
8. Compliance with spectacle wear: Parents ensure that the child wears glasses for ≥8 hours per day;
9. Follow-up capability: Ability to attend scheduled follow-ups for 12 months (4 visits in total);
10. Informed consent from guardian: Legal guardian signs the informed consent form; children also sign the assent form.

Exclusion Criteria:

1. History or presence of glaucoma, corneal disease, or other ocular organic disease, or acute or chronic ocular inflammation;
2. Combined with systemic major diseases, mental diseases, or systemic collagen metabolism diseases;
3. Used any myopia intervention drugs or devices in the past 3 months;
4. Those who have participated in other similar clinical studies in the past 3 months;
5. Diagnosis of amblyopia, constant strabismus, and other congenital eye diseases;
6. Those who are allergic to the lens material or products related to the study;
7. Allergy to mydriatic agents and related ophthalmic medications;
8. Allergic to photochromic materials or related dyes; taking photosensitizing drugs; suffering from photo-induced skin or neurological disorders;
9. Unable to understand the study content or unable to cooperate with the follow-up;
10. Other reasons why the research doctor believes the patient is not suitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	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.
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.	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.
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	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
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)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Estimated): April 15, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: April 1, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: QX-2025-A-021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No