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Combined orthokeratology with different administration time and dosages of 0.01% atropine treatment for fast progressing myopic children

Combined orthokeratology with different administration time and dosages of 0.01% atropine treatment for fast progressing myopic children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096722
Enrollment
Unknown
Registered
2025-02-05
Start date
2024-03-11
Completion date
Unknown
Last updated
2025-02-10

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

Conditions

myopia

Interventions

Group qn:None
Group bid:None
Group A:Each eye receives one drop of 0.01% atropine after removing orthokeratology lenses every morning
Group B:Each eye receives one drop of 0.01% atropine 10 mins before wearing orthokeratology lenses every night
Group C:Each eye receives two drops of 0.01% atropine, before and after orthokeratology lens insertion, as described for Groups A and B

Sponsors

The Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 14 Years

Inclusion criteria

Inclusion criteria: Retrospective part: (1) Age 8-14 (2) Both eyes exhibit myopia (3) Participants have been wearing orthokeratology lenses for there months before using 0.01% atropine eye drops (4) Participants have not been treating with any other drugs for myopia control before using 0.01% atropine eye drops Prospective part: (1) Age between 8 and 14 years (2) Both eyes exhibit myopia with spherical equivalent ranging from -6.00 to -1.00 D, astigmatism less than 2.00 D, anisometropia < 1.00 D, and best-corrected visual acuity not less than 4.9 (3) Intraocular pressure within the range of 10 to 21 mmHg, with an inter-eye pressure difference not exceeding 5 mmHg (4) Participants have been wearing orthokeratology lenses for six months to two years, with an axial length increase of 0.20mm or more over six months

Exclusion criteria

Exclusion criteria: Retrospective part: (1) Discontinue to wear orthokeratology lenses after using 0.01% atropine eye drops (2) Discontinue to use 0.01% atropine eye drops (3) Lack of the axial length data Prospective part: (1) History of allergy to atropine or anticholinergic medications (2) Prior use of low-concentration atropine eye drops (3) Inability to ensure regular follow-up and timely medication adherence (4) Presence of other ocular or systemic diseases (5) Congenital myopia, pathological myopia, premature birth, and low birth weight (<=1500g)

Design outcomes

Primary

MeasureTime frame
axial length elongation;

Secondary

MeasureTime frame
choroidal parameters;

Countries

China

Contacts

Public ContactJiang Jun

The Eye Hospital of Wenzhou Medical University

jiangjwz@wmu.edu.cn+86 135 0651 1080

Outcome results

None listed

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