Skip to content

Double-blind, randomized controlled, potent, multicenter clinical trials of soft hydrophilic contact lenses for delaying myopia progression in children

Double-blind, randomized controlled, potent, multicenter clinical trials of soft hydrophilic contact lenses for delaying myopia progression in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077005
Enrollment
Unknown
Registered
2023-10-26
Start date
2023-10-31
Completion date
Unknown
Last updated
2023-10-30

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

Conditions

Ametropia

Interventions

Experimental group:Wear soft contact lens
Control group:Wear soft hydrophilic contact lenses

Sponsors

Optometry Hospital Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) The objective optometry under mydilation of both eyes was between -1.00D (inclusive) and -8.00D (inclusive), and the best corrected visual acuity of left and right eye was greater than or equal to 1.0; (2) The written consent of the guardian is required, regardless of gender; Have good wearing compliance, willing to complete the visit, children and guardians sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) have a systemic disease that may affect the eye within 1 year prior to signing the informed consent, such as diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis, or a history of sinusitis within 2 years, or other diseases that the investigator considers impossible to wear contact lenses; (2) Simultaneous use of any topical ophthalmic or systemic medications that may interfere with contact lens fitting/require contact lens removal during the day. Common drugs that affect vision include tricyclic depressants, phenothiazines, general anesthetics, immunomodulators, etc. (3) suffer from various eye diseases within 3 months before signing the informed consent, and cannot be worn by the researcher; (4) dry eyes who are in use within 1 month before signing the informed consent or plan to use drug intervention during the study, and the eye condition of the subject determined by the investigator, combined with their recent drug use, is not suitable for wearing contact lenses; (5) Have a history of eye trauma or corneal surgery that affects the wearing of contact lenses; (6) There is any situation in which the researcher determines that it is not suitable to wear a soft hydrophilic contact lens.

Design outcomes

Primary

MeasureTime frame
The equivalent spherical degree (SER) increase after cycloplegia;

Secondary

MeasureTime frame
Axial length (AL) increase (mm);

Countries

China

Contacts

Public ContactJia Qu

Optometry Hospital Affiliated to Wenzhou Medical University

jiaqu@163.com+86 138 0689 8805

Outcome results

None listed

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