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OpenTrials
Enrolling by Invitation

NCT Number: NCT06221592

Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses

To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.

Enrolling by Invitation

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Key information

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 0.00D~-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 spectacle lenses

Device

To evaluate the differences in controlling the progression of myopia in adolescents and the safety and comfort of wearing different types of defocus incorporated multiple segments spectacle lenses, to explore the feasibility of effective defocus micro lens design, and apply personalized defocus frame lenses for myopia prevention and control.

Primary outcomes

  1. Axial length

    Time frame: 2 years

    The change of axial length.

Secondary outcomes

  1. Subjective refraction equivalent spherical

    Time frame: 2 years

    The change of Subjective refraction equivalent spherical

Sponsors and collaborators

Lead sponsor

Shanghai Eye Disease Prevention and Treatment Center

Other

Registry information

Official study title

Differences and Wearing Safety and Comfort of New Defocus Incorporated Multiple Segments Spectacle Lenses in Myopia Prevention and Control

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 24, 2024
Registry last updated
Oct 1, 2024

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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