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Effects of peripheral myopic defocus spectacle lens wear on prevention and retardtion in mopic children: a randomized, parallel controlled clinical trial

Effects of peripheral myopic defocus spectacle lens wear on prevention and retardtion in mopic children: a randomized, parallel controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063036
Enrollment
Unknown
Registered
2022-08-29
Start date
2022-09-10
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

myopia

Interventions

Group 1 :Peripheral myopic defocus lenses (produce myopic defocus - 4.50D)
Group 2:Peripheral myopic defocus lenses (produce myopic defocus - 3.50D)
Group 3:Peripheral myopic defocus lenses (produce myopic defocus - 2.50D)
Group 4:Monopolitical lens
Group 5(Second Year):Peripheral myopic defocus lenses (produce myopic defocus - 4.50D) identical to the first year
Group 6(Second Year):Peripheral myopic defocus lenses (produce myopic defocus - 3.50D in first year changed to - 4.50D in second year)
Group 7(Second Year):Peripheral myopic defocus lenses (produce myopic defocus - 2.50D in first year changed to - 4.50D in second year)
Group 8(Second Year):Peripheral myopic defocus lenses (single-vision changed to produce myopic defocus - 4.50D in second year)
Group 9(External control):single vision lenses

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age between 8-12 years old; 2. Myopia diopter: between -0.75-4.00D; 3. Spherical anisometropia = 1.0 (decimal recording method); 5. The refractive medium of the subject's eye is clear.

Exclusion criteria

Exclusion criteria: 1. Shallow anterior chamber or intraocular pressure > 20 mHg; 2. Suffering from keratitis, pink eye, acute inflammation around the eyes, glaucoma and other eye diseases; 3. Persons with mental retardation or mental illness; 4. Wearers of contact lenses (including those who wear contact lenses during the test); 5. Cardiopulmonary insufficiency; 6. Severe eye discomfort; 7. Wearers with insufficient adjustment; 8. The subject requests to withdraw from the clinical trial; 9. Those who have poor compliance and are considered by the investigators to be inappropriate to continue participating in this clinical trial; 10. Other myopia control methods have been used within the past year, such as orthokeratology lenses, defocused soft contact lenses, defocused frame glasses, atropine, etc.

Design outcomes

Primary

MeasureTime frame
spherical refraction;axial length;visual performance questionnaire;binocular vision function;

Secondary

MeasureTime frame
visual acuity;intraocular pressure;contrast sentivity;accommodative response;Peripheral refraction;choroidal thickness;choroidal vessel density;anterior chamber depth;corneal curvature;corneal thickness; lens thickness;lens power;astigmatism; vitreous chamber depth;

Countries

China

Contacts

Public ContactLongqian Liu

West China hospital of Sichuan University

b.q15651@hotmail.com+86 189 8060 1759

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026