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Active, Not Recruiting

NCT Number: NCT06927414

Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents

This study aims to evaluate the effectiveness of lenses with light diffraction glasses 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Myopia Progressing

Age range

6 year–8 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: Yes

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

Inclusion criteria

  • Age: 6-8 years old;
  • After using 1% cyclohexanone hydrochloride eye drops (Saifeijie) for ciliary muscle paralysis, binocular spherical power were within 0.00D~-1.75D, binocular cylinder power ≤ 1.50D, the anisometropia is less than 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 6 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.

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

Functional lens

Device

Diffractive Optical Element, D.O.E, technology for controlling myopia progression in children and adolescents. 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: 3 months

Secondary outcomes

  1. Axial length

    Time frame: 3 months

  2. Choroidal thickness

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

Exploratory Study on the Effectiveness and Safety of Light Diffraction Frame Glasses in Preventing and Controlling Myopia in Children and Adolescents

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 15, 2025
Registry last updated
Apr 15, 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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