NCT07284147

Brief Summary

This study aims to evaluate the effectiveness of lenses with 3D Designed Defocus in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective design, and apply personalized frame lenses for myopia prevention and control.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Aug 2027

Study Start

First participant enrolled

September 1, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2027

Expected
Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 3, 2025

Last Update Submit

December 3, 2025

Conditions

Myopia Progressing

Keywords

myopia

Outcome Measures

Primary Outcomes (1)

  • Subjective refraction equivalent spherical

    Subjective refraction equivalent spherical

    12 months

Secondary Outcomes (2)

  • Axial length

    12 months

  • Choroidal thickness

    12 months

Study Arms (2)

Experimental: 3D lens

EXPERIMENTAL

3D Designed Defocus Lenses

Device: Defocus Lenses

Control: H. A. L. T, highly aspheric lenslet technology

ACTIVE COMPARATOR

H. A. L. T, highly aspheric lenslet technology

Device: Defocus Lenses

Interventions

Defocus LensesDEVICE

Defocus Lenses on Myopia Control

Control: H. A. L. T, highly aspheric lenslet technologyExperimental: 3D lens

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age: 6-14 years old; After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within -0.40D\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is ≤ 1.50D, the progression of myopia in the past year is greater than 0.5D, the best corrected far vision is at least 4.8, and the near vision is at least 5.0; Within 3 months, the myopia prevention and control methods such as multifocal glasses, orthokeratology, defocusing flexible glasses, progressive glasses, atropine eye drops, red light and acupuncture and moxibustion treatment were not used; The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University

Shanghai, China

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2025

First Posted

December 16, 2025

Study Start

September 1, 2025

Primary Completion

February 1, 2026

Study Completion (Estimated)

August 31, 2027

Last Updated

December 16, 2025

Record last verified: 2025-12

Locations

CN(1)