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Analysis of Influencing Factors and Prediction Research on the Efficacy of Orthokeratology Lenses

Study on the Analysis of the Efficacy Mechanism and Construction of a Prediction Model for Orthokeratology Lenses

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500106747
Enrollment
Unknown
Registered
2025-07-29
Start date
2025-08-20
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

myopia

Interventions

Orthokeratology Lenses group:none

Sponsors

Changsha Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1.The research subjects are children and adolescents aged 8 to 14 with myopia; 2.Myopia refractive power: equivalent spherical power: -0.50 D to -6.00 D; 3.Corneal curvature, corneal diameter, and biological measurement parameters meet the fitting standards for OK lenses; 4.There are no other organic eye diseases or systemic immune or metabolic diseases; 5.Before the study, informed consent forms (signed by the guardians) were signed and the participants were willing to cooperate in long-term follow-up.

Exclusion criteria

Exclusion criteria: 1.Abnormal refractive status: hyperopia, mixed astigmatism or high astigmatism (astigmatism > 1.50 D); 2.Active ocular infections, inflammation, dry eye syndrome or abnormal corneal epithelial integrity; 3.Abnormal ocular structures such as corneal dystrophy, keratoconus, abnormal intraocular pressure, etc.; 4.Previous refractive surgery or other interventional myopia control treatments; 5.Possible relocation during the study period or inability to complete long-term follow-up; 6.Genetic metabolic disease history or familial eye diseases (such as glaucoma, retinopathy, etc.); 7.Individuals who are unwilling to cooperate with genetic testing or behavioral monitoring.

Design outcomes

Primary

MeasureTime frame
increase in axial length (mm);peripheral refractive defocus change;eye behavior indicators;genetic parameters;refractive status change (D);

Secondary

MeasureTime frame
corneal morphology;pupil diameter;Withdrawal rate and compliance monitoring;Abnormal warning indicators of biomechanical changes;Incidence of serious adverse events;

Countries

China

Contacts

Public ContactYuanfang Yang

Changsha Aier Eye Hospital

yuanfang.yang@foxmail.com+86 15580030569

Outcome results

None listed

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