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Safety and efficacy of biothin vision multifocal soft contact lens and Orthokeratology (CRT) in delaying myopia progression: a clinical controlled trial

Safety and efficacy of biothin vision multifocal soft contact lens and Orthokeratology (CRT) in delaying myopia progression: a clinical controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100048452
Enrollment
Unknown
Registered
2021-07-09
Start date
2018-07-19
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

myopia

Interventions

MFSCL:multifocal soft contact lenses
Group 2:Single light frame glasses

Sponsors

The First Affiliated Hospital of Medical College of Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Myopic children aged 7-15, regardless of gender; 2. The subjects with myopia between - 1.00d and - 8.00d, corneal astigmatism = 75D in the last year; 4. Subjects who can complete at least 12 months follow-up; 5. They were able to understand the purpose of the trial and voluntarily participated in the trial. Informed consent was signed by the subjects themselves and their legal guardians.

Exclusion criteria

Exclusion criteria: 1. Suffering from systemic diseases that may affect the eye, such as diabetes, thyroid abnormalities, arthritis, allergic diseases and so on, which can not be worn by ophthalmologists. 2. Patients with various eye diseases, such as acute or chronic eye inflammation, glaucoma, corneal paresthesia above grade 2, corneal epithelial defect, corneal endothelial cell reduction, dry eye, etc., which cannot be worn by ophthalmologists; 3. There were corneal abnormalities; Patients who have undergone corneal surgery, or have a history of corneal trauma, active keratitis (such as corneal infection), corneal limbal exophthalmos, severe ptosis or nearby bulge area; 4. The best corrected visual acuity of frame glasses was lower than 0.8; 5. It is not suitable to wear contact lenses in living or working environment, such as dust, medicine, aerosol (such as hair gel, volatile chemicals), dust, etc; 6. The subjects who could not use contact lens as required, could not have regular eye examination and had unstable refraction; 7. Those who do not have the necessary personal hygiene conditions for wearing contact lenses; 8. Patients with strabismus, amblyopia and abnormal eye position; 9. Subjects who had previously worn other myopia control treatment, and subjects who had previously used atropine or pirenzepine within 30 days; 10. Subjects with allergic history of contact lens or contact lens care products; 11. The results showed that the subjects with contraindications or unsuitable for wearing contact lenses; 12. History of ocular trauma or intraocular surgery; 13. Those who participated in clinical trials of other drugs or medical devices within 30 days before screening; 14. Those who are not supervised or can not follow up according to the doctor's advice; 15. The researchers judged that the patients were not suitable for other conditions.

Design outcomes

Primary

MeasureTime frame
Axial length;SER;

Countries

China

Contacts

Public ContactDu Chi-Xin

The First Affiliated Hospital of Medical College of Zhejiang University

duchixin@zju.edu.cn+86 13958100380

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026