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

NCT06860737 | Active Not Recruiting

• 1 other identifier: WS10405
• Study Type: interventional
• Target: 388
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopic Children

Keywords

pre-myopic children; evaluation; intervention; comliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Changes of spherical equivalent under cycloplegia

  From enrollment to the end of intervention for one year

• Changes of axial length

  From enrollment to the end of intervention for one year

• Changes of choroidal thickness

  From enrollment to the end of intervention for one year

• 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

  From enrollment to the end of intervention for one year

Other Outcomes (3)

• 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)

  From enrollment to the end of intervention for one year

• Assessment of symptoms, complaints related to the study intervention, as reported by participants.

  From enrollment to the end of intervention for one year

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Objectively measuring outdoor time by smart bracelet.

Interventions

Novel plano spectacle lenses DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Essilor International: collaborator

Study Sites (1)

Xiangui He

Shanghai, 200040, China

Location

Related Publications (1)

• 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.

  PMID: 40976937 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: March 2, 2025
• First Posted: March 6, 2025
• Study Start: March 15, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)