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OpenTrials
Completed

NCT Number: NCT06926556

Different Microlenses Array for Controlling Myopia Progression in Children and Adolescents

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.

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Key information

Conditions

Myopia Progressing

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200050, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • Diagnosed constant strabismus;
  • Diagnosed pathological myopia;
  • Other congenital eye diseases;
  • Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.

Treatment and study plan

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.

Primary outcomes

  1. Subjective refraction equivalent spherical

    Time frame: 2 years

Secondary outcomes

  1. Axial length

    Time frame: 2 years

Other outcomes

  1. Other biological parameters

    Time frame: 2 years

    amplitude of accommodation, anterior chamber depth, corneal curvature, white to white distance, central corneal thickness, lens thickness ,pupil size, multispectral refraction topography, choroidal thickness, objective visual quality, wavefront aberration, contrast sensitivity, and strabismus (mahalanobis bar method).

  2. Best corrected visual acuity

    Time frame: 2 years

  3. questionnaires of daily eye habits and wearing time of subjects collected

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

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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