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Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06927414
Enrollment
40
Registered
2025-04-15
Start date
2025-02-01
Completion date
2025-06-30
Last updated
2025-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia Progressing

Brief summary

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.

Interventions

DEVICEFunctional lens

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.

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age: 6-8 years old; 2. 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; 3. 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; 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.

Design outcomes

Primary

MeasureTime frame
Subjective refraction equivalent spherical3 months

Secondary

MeasureTime frame
Axial length3 months
Choroidal thickness3 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 18, 2026