Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial

Pre-myopia refers to a condition in which children have not yet developed myopia but exhibit insufficient hyperopic reserve (≤ +0.75 D). This is particularly relevant for young children aged 6 years and under; if their hyperopic reserve is depleted prematurely and they progress into the pre-myopia stage, the likelihood of developing myopia or even high myopia in the future becomes extremely high. Therefore, this study plans to conduct a parallel-design, open-label, single-center randomized controlled clinical trial to evaluate the efficacy and safety of artificial intelligence-assisted defocus incorporated multiple segments (DIMS) based spectacle lens in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.

Study Overview

• Status: Not yet recruiting
• Conditions: Myopia; Pre-myopia
• Intervention / Treatment: Device: Smartwatches; Device: Artificial Intelligence Assisted DIMS based Spectacle Lens

• Study Type: Interventional
• Enrollment (Estimated): 128
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangui He, Prof; Phone Number: +86 15000755422; Email: xianhezi@163.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China
      • Shanghai Eye Disease Prevention and Treatment Center
      • Contact: Tianyu Cheng, Dr; Phone Number: +86 18817552005; Email: s70444@126.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age between 3 and 6 years (inclusive), regardless of gender or ethnicity.
• Cycloplegic spherical equivalent refraction (SER) of the worse eye > -0.50 D and ≤ +0.75 D, absolute cylindrical power ≤ 1.0 D, anisometropia ≤ 1.5 D.
• Best corrected monocular distance high contrast VA ≥ 0.5 for ages 3-5; ≥ 0.7 for age 6.
• At least one parent with SER ≤-3.00D

Exclusion Criteria:

• Individuals with any ocular or systemic diseases that may affect vision and refractive development (e.g., keratoconus, abnormalities in lens shape or position, Marfan syndrome, retinopathy of prematurity, etc.).
• Individuals with known allergies or contraindications to cycloplegic agents.
• Previous use of myopia management treatment (spectacles, atropine; CLs).
• Individuals with binocular vision abnormalities: manifest strabismus, monocular suppression, abnormal fusion function, or impaired stereopsis.
• Individuals unable to cooperate with examinations or communicate.
• Any other conditions deemed by the investigator as unsuitable for participation in 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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control group; Wear smartwatches	Device: Smartwatches; Inserted prompt system of the smartwatches can remind the users to go outside. Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc.
Experimental: Intervention group; Wear AI-assisted DIMS-based spectacle lens (at least 10 hours a day), as well as smartwatches	Device: Smartwatches; Inserted prompt system of the smartwatches can remind the users to go outside. Inserted sensors can record outdoor parameters such as outdoor time, light intensity, activity pattern, etc.; Device: Artificial Intelligence Assisted DIMS based Spectacle Lens; The AI-DIMS defocus spectacle frame, featuring DIMS-based lenses and an intelligent AI frame, is designed to be worn for at least 10 hours per day. The frame automatically tracks and records wearing duration parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in axial length	From baseline to the 12-month follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in Cycloplegic Spherical Equivalent Refraction (SER)	From baseline to the 12-month follow-up
Changes in Choroidal Thickness (CT)	From baseline to the 12-month follow-up
Spectacle-wearing compliance and spectacle-wearing time	From baseline to the 12-month follow-up

Other Outcome Measures

Outcome Measure	Time Frame
Changes in Pupil Diameter	From baseline to the 12-month follow-up
Changes in Intraocular Pressure (IOP)	From baseline to the 12-month follow-up
Changes in Best Corrected Visual Acuity	From baseline to the 12-month follow-up
Adverse event profile	At 12-month follow-up

Collaborators and Investigators

• Sponsor: Shanghai Eye Disease Prevention and Treatment Center
• Collaborators: HOYA Lens Thailand LTD.
• Investigators: Principal Investigator: He, Prof, Shanghai Eye Disease Prevention and Treatment Center

Study record dates

Study Major Dates

• Study Start (Estimated): September 12, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: August 11, 2026
• First Submitted That Met QC Criteria: August 11, 2026
• First Posted (Actual): August 14, 2026

Study Record Updates

• Last Update Posted (Actual): August 18, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: young children; pre-myopia; AI-assisted DIMS-based spectacle lens
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: IIT2026-003-AMD-01

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