NCT07765550

Brief Summary

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 Triple Enhanced Design (AI-DIMS) spectacle lenses in preventing and controlling myopia in pre-myopic children aged 3 to 6 years.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2026

Completed
29 days until next milestone

Study Start

First participant enrolled

September 12, 2026

Expected
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2028

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

August 14, 2026

Status Verified

August 1, 2026

Enrollment Period

1.7 years

First QC Date

August 11, 2026

Last Update Submit

August 11, 2026

Conditions

Pre-myopiaMyopia

Keywords

pre-myopiaDIMS-TEDyoung children

Outcome Measures

Primary Outcomes (1)

  • Changes in axial length

    From baseline to the 12-month follow-up

Secondary Outcomes (3)

  • 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 Outcomes (4)

  • 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

  • +1 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Wear AI-DIMS TED spectacle lenses (at least 10 hours a day), as well as smartwatches

Device: Artificial Intelligence-Assisted Defocus Incorporated Multiple Segment Triple Enhanced Design (AI-DIMS TED) Spectacle LensesDevice: Smartwatches

Control group

OTHER

Wear smartwatches

Device: Smartwatches

Interventions

Artificial Intelligence-Assisted Defocus Incorporated Multiple Segment Triple Enhanced Design (AI-DIMS TED) Spectacle LensesDEVICE

The AI-DIMS TED defocus spectacle frame, featuring DIMS TED 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.

Intervention group
SmartwatchesDEVICE

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.

Control groupIntervention group

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • He, Prof

    Shanghai Eye Disease Prevention and Treatment Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangui He, Prof

CONTACT

+86 15000755422xianhezi@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2026

First Posted

August 14, 2026

Study Start (Estimated)

September 12, 2026

Primary Completion (Estimated)

May 31, 2028

Study Completion (Estimated)

August 31, 2028

Last Updated

August 14, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)