Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents

NCT06926556 | Completed

• 1 other identifier: QX-2024-A-003
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of lenses with different defocused microlens array in controlling the progression of myopia in children and adolescents, and to explore the feasibility of effective defocus microlens design, and apply personalized defocus frame lenses for myopia prevention and control.

Conditions

Myopia Progressing

Outcome Measures

Primary Outcomes (1)

• Subjective refraction equivalent spherical

  2 years

Secondary Outcomes (1)

• Axial length

  2 years

Other Outcomes (3)

• Other biological parameters

  2 years

• Best corrected visual acuity

  2 years

• questionnaires of daily eye habits and wearing time of subjects collected

  2 years

Study Arms (2)

H.M.E.C，High Precision Micro Encircle

EXPERIMENTAL

Device: Defocus microlenses

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

ACTIVE COMPARATOR

Interventions

Defocus microlenses DEVICE

Different microlenses array (H.M.E.C，High Precision Micro Encircle and H.A.L.T, highly aspheric lenslet technology) for controlling myopia progression in children and adolescents.

H.M.E.C，High Precision Micro Encircle

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (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 -0.50D\~-4.00D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 1.50D, and the best corrected visual acuity was above 5.0;
• Within 30 days, 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.

You may not qualify if:

• Diagnosed constant strabismus;
• Diagnosed pathological myopia;
• Other congenital eye diseases;

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200050, China

Location

Study Design

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

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: April 13, 2025
• Study Start: August 1, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

CN (1)