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Clinical trial of visual performance and eye movement after wearing two different designs of multifocal soft contact lenses

Clinical trial of visual performance and eye movement after wearing two different designs of multifocal soft contact lenses

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034929
Enrollment
Unknown
Registered
2020-07-24
Start date
2020-07-15
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

ametropia

Interventions

Group A:Wearing DISC first, and then Triocurve lens
Group B:Wearing Triocurve lens first, and then DISC

Sponsors

Tianjin Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Aged 8-15 year-old myopia, male or female; 2. Subject Refraction: -1.00D <= Equal Sphere <= -10.00D, with-rule astigmatism <= 1.50D;against-rule astigmatism <= 0.75D; 3. Corneal curvature is between 39.0D and 46.0Dand the astigmatism is less than 1.50D; 4. Being able to wear the lens and complete all the follow-up as the stipulate in the plan; 5. Being able to understand the purpose of the test, participating voluntarily and signing the informed consent form by the subject himself and his legal guardian.

Exclusion criteria

Exclusion criteria: 1. Patients with systemic diseases that may affect the eyes, such as diabetes, thyroid abnormalities, arthritis, allergic diseases, etc., the patients that can not wear contact lens judged by ophthalmologist; 2. With all kinds of eye disease, such as acute or chronic inflammation of the eye, glaucoma, secondary or more abnormal corneal sensation, deficiency of corneal epithelium, reduced corneal endothelial cells, dry eyes, etc., the patients that can not wear contact lens judged by ophthalmologist; 3. Abnormal cornea;Patients with corneal surgery, history of corneal trauma, active keratitis (such as corneal infection, etc.), corneal limbus protrusion, severe blepharoptosis, or nearby uplift areas; 4. The best corrected vision for the spectacle was less than 0.8; 5. Living or working conditions are not suitable for wearing contact lenses, such as dispersing dust, drugs, aerosol (such as hairspray, volatile chemicals), dust, etc. 6. Can not use contact lens and do eye examinations as required, and refractive instability; 7. Personal hygiene conditions do not meet the requirement to wear contact lenses; 8. Strabismus patients, amblyopia and abnormal ocular position; 9. Subjects who have worn Ortho-K and have used atropine or pirenzepine in the last 30 days; 10. Subject of allergic history of contact lens or contact lens care products; 11. The test results indicate that subjects with contraindications or not suitable to wear corneal contact lenses; 12. Having a history of ocular trauma or intraocular surgery; 13. Participated in clinical trials of other drugs or medical devices within 30 days; 14. Unsupervised or unable to follow the advice of the doctors; 15. Other situations that the patients were not suitable judged by the researchers.

Design outcomes

Primary

MeasureTime frame
Corneal topography;Peripheral refraction;Eye tracker;binocular vision function;visual performance;

Countries

China

Contacts

Public ContactXiaoyan Yang

Tianjin Eye Hospital

yanzi2006tj@sina.com+86 022-27306525

Outcome results

None listed

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