Light Diffraction Glasses in Preventing and Controlling Myopia in Adolescents

NCT06927414 | Active Not Recruiting

• 1 other identifier: XSKHR2024-058-006
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia Progressing

Outcome Measures

Primary Outcomes (1)

• Subjective refraction equivalent spherical

  3 months

Secondary Outcomes (2)

• Axial length

  3 months

• Choroidal thickness

  3 months

Study Arms (2)

Light diffraction lens (Diffractive Optical Element , D.O.E)

EXPERIMENTAL

Device: Functional lens

H. A. L. T, highly aspheric lenslet technology

ACTIVE COMPARATOR

Device: Functional lens

Interventions

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.

H. A. L. T, highly aspheric lenslet technology; Light diffraction lens (Diffractive Optical Element , D.O.E)

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed constant strabismus;
• Diagnosed pathological myopia;
• Other congenital eye diseases;

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200050, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: April 15, 2025
• Study Start: February 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Locations

CN (1)