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NCT Number: NCT07765550

Myopia Prevention in Young Premyopic Children Using Defocus Incorporated Multiple Segments Spectacle Lenses

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.

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Key information

Conditions

Pre-myopia Eye Diseases Myopia Refractive Errors

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Eye Disease Prevention and Treatment Center

Shanghai, Shanghai Municipality, China

Location contact

Tianyu Cheng, Dr

CONTACT

[email protected]

+86 18817552005

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Device

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.

Smartwatches

Device

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.

Primary outcomes

  1. Changes in axial length

    Time frame: From baseline to the 12-month follow-up

Secondary outcomes

  1. Changes in Cycloplegic Spherical Equivalent Refraction (SER)

    Time frame: From baseline to the 12-month follow-up

  2. Changes in Choroidal Thickness (CT)

    Time frame: From baseline to the 12-month follow-up

  3. Spectacle-wearing compliance and spectacle-wearing time

    Time frame: From baseline to the 12-month follow-up

Other outcomes

  1. Changes in Pupil Diameter

    Time frame: From baseline to the 12-month follow-up

  2. Changes in Intraocular Pressure (IOP)

    Time frame: From baseline to the 12-month follow-up

  3. Changes in Best Corrected Visual Acuity

    Time frame: From baseline to the 12-month follow-up

  4. Adverse event profile

    Time frame: At 12-month follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Xiangui He, Prof

CONTACT

[email protected]

+86 15000755422

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Collaborators

  • HOYA Lens Thailand Limited

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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