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

NCT06221592 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Eye Disease Prevention and Treatment Center

Phase

Not applicable

Started

2024-03-01

Last updated

2024-10-01

Condition(s) studied

Myopia, Progressive

Investigational drug(s) / intervention(s)

defocus spectacle lenses

defocus 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

6 Years

Max age

14 Years

Healthy volunteers

Inclusion Criteria: 1. Age: 6-14 years old; 2. 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; 3. 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; 4. The subject has a willingness to receive treatment and an informed consent form is signed by their legal guardian. Exclusion Criteria: 1. Diagnosed constant strabismus; 2. Diagnosed pathological myopia; 3. Other congenital eye diseases; 4. Researchers believe that the patients have other reasons that are not suitable for inclusion in the project.

Primary outcome measure(s)

Axial length — 2 years
The change of axial length.

Trial sites (1)

Facility	City	Region	Status
Shanghai Eye Diseases Prevention &Treatment Center/ Shanghai Eye Hospital, School of Medicine, Tongji University	Shanghai	Shanghai Municipality

More Shanghai Eye Disease Prevention and Treatment Center trials in China

School-based Myopia Control Trial for Children With Premyopia or Myopia Recruiting

Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control Active, not recruiting

LED Red Light in Modulating Choroidal Microcirculation to Retard Retinal Atrophy in Pathological Myopia Recruiting

China Children Eye Study Recruiting

Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial Recruiting

Other trials for the same condition

Choroidal Change on OCTA in Eyes With High Myopia Starting soon

Double Helix Design Defocus Lens Spectacle (RACE) for Myopia Control Active, not recruiting

Myopia Progression With Freeform Myopia Control Spectacles Active, not recruiting

Safety and Efficacy of Blue Star MAX-5 Lenses in Myopia Control Active, not recruiting

Evaluation of the Safety and Efficacy of the D.D.C Dual-control Technology Spectacle Lenses in Delaying the Progression of Myopia: a Randomized Controlled Trial Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06221592 on ClinicalTrials.gov ↗ ← All trials in China