Ametropia
Conditions
Interventions
Experimental group:Wear DISC PM soft contact lens
Control group :Wear monthly soft contact lens
Sponsors
Optometry Hospital Affiliated to Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.18=3:1; 4. The best corrected visual acuity of left and right main sense optometry is greater than or equal to 5.0 note 1 (equivalent to 1.0 decimal visual acuity); 5. Able to understand the purpose of the trial, willing to participate in the clinical trial and sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Have a systemic disease that may affect the eyes, such as diabetes mellitus, Down syndrome, hyperthyroidism, rheumatoid arthritis, a history of sinusitis, or other diseases that are considered unsuitable for wearing contact lenses within 1 year before signing the informed consent; 2. Use any topical ophthalmic or systemic medications that may interfere with the fitting of the contact lens/require the lens to be removed during the day. Common drugs that affect vision include tricyclic depressants, phenothiazines, general anesthetics, immunomodulators, etc. 3. Suffered various eye diseases within 3 months before signing the informed consent, including but not limited to: Patients with acute or chronic ocular inflammation (chronic keratitis, chronic uveitis, chronic dacryocystitis, chronic blepharitis, iritis, seborrheic conjunctiva, etc.), glaucoma, corneal paresthesia, corneal epithelial defect, corneal endothelial cell depletion, cataract, keratoconus and irregular cornea, etc., should not be worn by researchers. 4. Dry eye injection (2) that is being used within 1 month prior to signing the informed consent or is planning to use drug intervention during the study period, and that the eye condition of the subject determined by the investigator is not suitable for wearing contact lenses in combination with recent drug use; Note 2: Drugs include drugs for dry eyes, such as artificial tears, calf serum extracts, non-steroidal anti-inflammatory drugs, etc. And the treatment of moderate and severe dry eye glucocorticoid, immunosuppressant and so on. 5. Patients with a history of ocular trauma or corneal surgery that affects the wearing of contact lenses; 6. Rupture time of tear film is less than or equal to 5s; 7. Abnormal intraocular pressure (intraocular pressure 21mmHg or binocular pressure difference > 5mmHg); 8. In any case where the researcher determines that the soft hydrophilic contact lens is not suitable for wearing, note 3; Note 3: In this clinical trial, the unsuitable conditions for wearing soft hydrophilic contact lenses are: (1) Eyelid abnormalities or infection; (2) Clinically significant slit-lamp findings (see Appendix 3 for details); (3) There are other active eye diseases. 9. The results of fundus examination do not meet the requirements of Appendix 3; 10. The results of corneal endothelial examination did not meet the requirements of Appendix 3; 11. Allergic patients who have used contact lenses, contact lens care products and/or fluorescein sodium stain strips; 12. People who wear soft hydrophilic contact lenses in special working or living environments such as dispersed dust, drugs, aerosol (such as hair spray, volatile chemicals) and dust for a long time; 13. Pregnant, lactating or planning to become pregnant at the time of inclusion; 14. Only one eye meets the entry criteria; 15. Unable to use the contact lens as required or unable to carry out regular eye examination; 16. Participants who have participated in other soft hydrophilic contact lens clinical trials within 1 week before signing the informed consent, or who have worn rigid breathable contact lenses or participated in other clinical trials (including rigid breathable contact lenses for orthokeratology) or concurrently participated in other clinical trials within 1 month before signing the informed consent; 17. Participants who have participated in drug clinical trials within 3 months before signing informed consent; 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One week after wearing the glasses, the left and right eye contact lenses corrected vision; | — |
Secondary
| Measure | Time frame |
|---|---|
| The left and right eyes were corrected by contact lenses on the day, 1 month and 3 months;Optimal corrected visual acuity in the left and right eye frames on screening, the day of wearing glasses and for 3 months of wearing glasses; | — |
Countries
China
Contacts
Public ContactJia Qu
Optometry Hospital Affiliated to Wenzhou Medical University
Outcome results
None listed