A Randomized Clinical Trial on the Effectiveness of Novel Plano Spectacle Lenses on Myopia Prevention in Pre-myopic Children

A Randomized Clinical Trial on the Effectiveness of Novel Spectacle Lenses for Myopia Prevention in Pre-myopic Children

Evaluate the efficacy, safety and wearing time compliance of novel plano spectacle lenses in delaying myopia onset in pre-myopic children and provide scientific basis for the development of myopia prevention strategies for children.

Study Overview

• Status: Active, not recruiting
• Conditions: Myopic Children
• Intervention / Treatment: Device: Novel plano spectacle lenses

Detailed Description

Children aged 6-9 years old with pre-myopia are randomly assigned to a control group and an intervention group at a 1:1 ratio. The intervention group uses novel plano spectacle lenses for at least 8 hours a day, and the control group doesn't receive any intervention. The efficacy of novel plano spectacle lenses in delaying myopia onset in pre-myopia children is evaluated by comparing the one-year incidence of myopia onset between intervention group and control group.

• Study Type: Interventional
• Enrollment (Estimated): 388
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200040
    • Xiangui He

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• At the time of signing the informed consent form, the subject's age must be ≥6 years and <10 years (6-9.99 years);
• Both eyes are not myopic (SE>-0.50D under cycloplegia) and at least one eye meets the pre-myopia condition ( -0.50D< SE under cycloplegia ≤+0.75D); [spherical equivalent (SE)=Sph+Cyl/2]
• Astigmatism ≤1.00D in each eye;
• Difference in SER (Anisometropia) between the two eyes should not exceed ≤1.50D;
• Unaided distance and near visual acuity of at least 0.1 logMAR in each eye ;
• Be in good general health;
• Be able to actively cooperate with the intervention plan and ophthalmological examination;
• Normal binocular vision
• At least one parent with SER ≤-3.00 D

Exclusion Criteria:

• Incapable of expressing consent
• All categories of persons particularly protected by law
• Subject in another study which might have an influence on vision or interfere with study assessment.
• Previous use of other prevention solutions, such as but not limited to red light therapy within 6 months, Atropine and other interventions were used within 3 months;
• History or presence of an ocular disease, systemic disease, strabismus or amblyopia or other binocular vision abnormalities, accommodation dysfunction, cataract and eye surgery;
• Those who are allergic cycloplegic drugs;
• Other reasons that the investigator considers inappropriate for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.	Device: Novel plano spectacle lenses; Use of novel plano spectacle lenses for at least 8 hours a day with objective wearing time measured by smart frame and objective outdoor time measured by smart bracelet.
No Intervention: Control group; Objectively measuring outdoor time by smart bracelet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One-year cumulative myopia incidence in either eye	One-year cumulative myopia incidence in either eye	From enrollment to the end of intervention for one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of spherical equivalent under cycloplegia	Changes of spherical equivalent under cycloplegia	From enrollment to the end of intervention for one year
Changes of axial length	Changes of axial length	From enrollment to the end of intervention for one year
Changes of choroidal thickness	Changes of choroidal thickness	From enrollment to the end of intervention for one year
Changes of unaided distance visual acuity	Changes of unaided distance visual acuity	From enrollment to the end of intervention for one year
Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses	Changes of visual acuity with novel spectacle lenses and Single Vision spectacle lenses	From enrollment to the end of intervention for one year
Changes of accommodation function	Changes of accommodation function	From enrollment to the end of intervention for one year
Wearing time recorded in the questionnaire and smart frame	Wearing time recorded in the questionnaire and smart frame	From enrollment to the end of intervention for one year
Objective outdoor time recorded with smart bracelet	Objective outdoor time recorded with smart bracelet	From enrollment to the end of intervention for one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of adverse events (AEs) related to study intervention	Incidence and severity of adverse events (AEs) related to study intervention	From enrollment to the end of intervention for one year
Monocular best-corrected visual acuity (BCVA)	Monocular best-corrected visual acuity (BCVA)	From enrollment to the end of intervention for one year
Assessment of symptoms, complaints related to the study intervention, as reported by participants.	Assessment of symptoms, complaints related to the study intervention, as reported by participants.	From enrollment to the end of intervention for one year

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Collaborators: Essilor International

Publications and helpful links

General Publications

• Wang J, Du L, Chen J, Zhang B, Yang J, Du Y, Gao W, Zou H, Xu X, He X. A randomized clinical trial on the effectiveness of plano spectacle lenses with lenslets on myopia prevention in pre-myopic children: Study protocol of a randomized controlled trial. Acta Ophthalmol. 2025 Sep 21. doi: 10.1111/aos.70007. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 2, 2025
• First Posted (Actual): March 6, 2025

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: intervention; evaluation; pre-myopic children; comliance
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: WS10405

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No