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

NCT06221592 | Enrolling By Invitation DMC

• 1 other identifier: QX-2023-A-03
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Myopia, Progressive

Outcome Measures

Primary Outcomes (1)

• Axial length

  The change of axial length.

  2 years

Secondary Outcomes (1)

• Subjective refraction equivalent spherical

  2 years

Study Arms (4)

Full axis multi-point defocus spectacle lenses

EXPERIMENTAL

Device: defocus spectacle lenses

Innovative micro defocus spectacle lenses

EXPERIMENTAL

Device: defocus spectacle lenses

Circular multi-point optical micro transparent defocus spectacle lenses

EXPERIMENTAL

Device: defocus spectacle lenses

High non spherical micro transparent defocus spectacle lenses

PLACEBO COMPARATOR

Device: defocus spectacle lenses

Interventions

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.

Circular multi-point optical micro transparent defocus spectacle lenses; Full axis multi-point defocus spectacle lenses; High non spherical micro transparent defocus spectacle lenses; Innovative micro defocus spectacle lenses

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

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

MeSH Terms

Conditions

Myopia, Degenerative

Condition Hierarchy (Ancestors)

Myopia; Refractive Errors; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: December 17, 2023
• First Posted: January 24, 2024
• Study Start: March 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)