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A Prospective Clinical Investigation of the Impact of Orthokeratology Lenses with Varied Curve Zone on Visual Quality in Pediatric Myopia Patients

Analysis of Optical Quality and Contrast Sensitivity in Myopic Correction Using Orthokeratology Lenses with Varied Base Curve Zone Diameters

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100642
Enrollment
Unknown
Registered
2025-04-11
Start date
2025-04-16
Completion date
Unknown
Last updated
2025-04-14

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

Conditions

The specific diseases or symptoms encompassed in the research primarily pertain to myopia among adolescents and children. Myopia is a common refractive disorder of the eye, manifested as the focusing of parallel light rays in front of the retina when the eye is in a relaxed accommodative state, leading to indistinct vision of distant objects while near objects are relatively clear. In this study,

Interventions

BC5.0mm:Orthokeratology with different base arc designs
A 5.8mm orthokeratoscope with a base arc design:A 6.0mm orthokeratoscope with a base arc design

Sponsors

Hangzhou Xihu Zhijiang Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1.The age range is between 8 and 13 years old; 2.Myopia degree in both eyes ranged from -1.00D to -4.00D, with astigmatism less than 1.75D; 3.Initial fitting of orthokeratology lenses.

Exclusion criteria

Exclusion criteria: 1.The use of low-concentration atropine or other drugs affecting pupil size within three months; 2.A history of ophthalmic surgery; Ocular conditions impacting vision and refractive changes, such as cataracts or glaucoma; 3.Systemic diseases potentially affecting vision and refraction, such as diabetes mellitus; 4.Poor compliance, inability to adhere to scheduled follow-ups, or failure to cooperate during examinations.

Design outcomes

Primary

MeasureTime frame
Subjective Visual Quality Assessment Score;Whole-eye higher-order aberrations (HOA), including spherical aberrations (SA), coma, and trefoil aberrations;

Secondary

MeasureTime frame
The Influence of Axial Length and Corneal Topographic Shape on Control Effectiveness;Occurrences of eye pain, redness, vision impairment, and corneal epithelial injury were documented;

Countries

China

Contacts

Public ContactYan Liu

Hangzhou Xihu Zhijiang Eye Hospital

877613999@qq.com+86 571 8662 5857

Outcome results

None listed

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