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The effectiveness and safety of different degree defocus base curve designed orthokeratology in myopia progression

The effectiveness and safety of different degree defocus base curve designed orthokeratology in myopia progression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073068
Enrollment
Unknown
Registered
2023-06-30
Start date
2023-07-01
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Myopia

Interventions

Experimental group A:Wearing aspherical base curve orthokeratology with 3 D defocus
Experimental group B:Wearing aspherical base curve orthokeratology with 4.5 D defocus
Experimental group C:Wearing aspherical base curve orthokeratology with 6 D defocus
Control group:Wearing spherical base curve orthokeratology

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged 8-12 years old; 2.Visual acuity: Monocular 1.0 or better; 3. Refractive errors: manifest ocular refraction in either eye; Spherical refraction >= -4.00D and <= -0.75D; 4. Astigmatism <= 1.50DC for axis 180±30; 5. Anisometropia <= 1.0D, 6. Available for scheduled and unscheduled visits at the West China Hospital for 12 months after treatment commences; 7. Sleep at least eight hours per night

Exclusion criteria

Exclusion criteria: 1. Shallow anterior chamber or intraocular pressure > 21mmHg; 2. Suffering from keratitis, keratoconus, glaucoma, strabismus, amblyopia, and other eye diseases; 3. Suffering from mental illness; 4. Serious systemic history, such as cardiopulmonary insufficiency; 5. Participate in other clinical trials 30 days before screening 6. Have used any products that delay the progression of myopia, such as specially designed lenses such as orthokeratology lenses, multi-focal contact lenses, peripheral defocusing lenses, atropine drugs, red light therapy devices, etc.; 7. Poor compliance, researchers believe that it is not appropriate to continue to participate in this experiment.

Design outcomes

Primary

MeasureTime frame
Subjective and objective refraction;Visual acuity;Wavefront aberration;Corneal topography;Axial length;Contrast sensitivity;multispectral refraction topography;Optical coherence tomography;Visual quality questionnaire;

Secondary

MeasureTime frame
Corneal endothelial cell;

Countries

China

Contacts

Public ContactLiu Longqian

West China Hospital, Sichuan University

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

Outcome results

None listed

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