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Clinical Study on Myopic Children Wearing Orthokeratology Lenses with Different Reverse Curve Heights

Clinical Study on Myopic Children Wearing Orthokeratology Lenses with Different Reverse Curve Heights

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118287
Enrollment
Unknown
Registered
2026-02-04
Start date
2026-02-11
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Myopia

Interventions

Conventional Reverse Curve Height Group:Orthokeratology lenses with conventional reverse curve height
Increased Reverse Curve Height Group:Orthokeratology lenses with increased reverse curve height

Sponsors

West China hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1) Age 8–14 years, with myopia between -0.50 D and -4.00 D, and astigmatism =0.50 D per year (based on records from the past 12 months); (5) No history of wearing orthokeratology lenses, defocus soft contact lenses, or other contact lenses; (6) Ocular health with no significant ocular diseases (e.g., keratoconus, severe dry eye); (7) Central corneal thickness >=480 µm, and intraocular pressure within the normal range of 10–21 mmHg; (8) Environmental and hygienic conditions suitable for wearing orthokeratology lenses; (9) Ability to understand the mechanism and practical effects of orthokeratology lenses, good compliance, timely and regular follow-up visits, and ability to understand and cooperate with the washout process arranged in this study; (10) The participant and their legal guardian voluntarily agree to participate in this study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Anisometropia >1.00 D; (2) Presence of amblyopia in one or both eyes; (3) Strabismus observed after full correction and cover testing (distance/near); (4) Ocular conditions that may affect refractive development or status (e.g., keratoconus, congenital glaucoma, ocular trauma, etc.) or systemic diseases (e.g., diabetes, connective tissue disorders such as Marfan syndrome, Down syndrome, etc.); (5) First-degree relatives (parents, siblings) with congenital night blindness or clinically diagnosed night vision disorders; (6) Known allergy to proparacaine, tetracaine, tropicamide, or cyclopentolate; (7) Abnormal binocular vision or stereopsis; (8) History of ocular surgery; (9) Corneal thickness 21 mmHg or <10 mmHg); (10) Other conditions deemed unsuitable for participation in this study as assessed by the investigator.

Design outcomes

Primary

MeasureTime frame
Axial length;Peripheral defocus;

Secondary

MeasureTime frame
Visual acuity;Subjective refraction;Objective refraction;Corneal Topography;Slit lamp examination;Intraocular pressure;Fundus examination;Specular microscope;

Countries

China

Contacts

Public ContactLongqian Liu

West China Hospital, Sichuan University

liulq@scu.edu.cn+86 189 8060 1759

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026