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Clinical study of combined orthokeratology (OK lens) and 0.01% atropine solution to control myopia progression in children

Clinical study of combined orthokeratology (OK lens) and 0.01% atropine solution to control myopia progression in children

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033904
Enrollment
Unknown
Registered
2020-06-16
Start date
2020-06-20
Completion date
Unknown
Last updated
2022-04-19

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

Conditions

Myopia

Interventions

experiment group:combined OK lens and 0.01% atropine solution
control group:combined OK lens and blank solvent

Sponsors

The First Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Patients are willing to wear OK glasses; 2. Patients aged 8-12 years; 3. The equivalent diopter of myopia is: - 1.0d ~ - 4.0d, astigmatism is less than - 1.5D; 4. The difference of equivalent spherical mirror degree of both eyes is less than 1.0D; 5. Corrected vision of far and near is greater than or equal to 1.0; 6. Patients with intraocular pressure of 10-21mmhg; 7. No eye active inflammation, no history of eye trauma, no history of eye surgery, no eye and systemic organic changes affecting vision.

Exclusion criteria

Exclusion criteria: 1. Patients with poor fit after wearing OK mirror for 2 months; 2. Patients with congenital myopia and pathological myopia, premature infants and low birth weight myopia; 3. Patients who can not be reexamined regularly according to regulations; 4. Patients who are allergic to atropine; 5. Patients who have used other drugs and training methods to control myopia (such as atropine, petoxipine, RGP and OK mirror).

Design outcomes

Primary

MeasureTime frame
spherical equivalent refractive errors;axial length;pupil diameter;amplitude of accommodation;

Secondary

MeasureTime frame
quality and quantity of tears;

Countries

China

Contacts

Public ContactAicun Fu

The First Affiliated Hospital of Zhengzhou University

fuaciun2019@qq.com+86 15093272336

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 11, 2026