Myopia diseases
Conditions
Interventions
Treatment Group:RGP lenses
Treatment Group:Care solution for treatment
Control Group:RGP lenses
control Group:Care solution for control
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years , regardless of gender; 2. Wear RGP contact lens with spherical Power range: +6.00D (inclusive) to -10.00D (inclusive); 3. Subjective refraction of astigmatism with the rule <= 2.50D; Subjective refraction of astigmatism against the rule or oblique astigmatism <= 1.50D; 4. The best corrected visual acuity of the left and right eyes is greater than or equal to 5.0 note 1 (equivalent to 1.0 decimal visual acuity); Note 1: Here and 5.0 below all refer to the visual acuity of the standard logarithmic visual acuity chart. Fractional visual acuity chart can be used in clinical practice to directly record fractional visual acuity, which can be uniformly converted to the standard logarithmic visual acuity during statistics. See Annex 3 for details. 5. Be able to understand the purpose of the trial, be willing to participate in the clinical trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Need to use therapeutic eye drops, including antibiotics, corticosteroid hormones and compound eye drops containing corticosteroid; 2. Suffer from certain eye conditions that affect the wearing of contact lenses: acute or chronic inflammation of the eye, catarronic conjunctivitis in spring, glaucoma, etc.; 3. Those who have used drug intervention for dry eye injection 2 within 30 days, and whose eye condition is examined by the investigator, and whose recent medication status is considered not to be able to wear rigid breathable contact lenses; Note 2: The drugs USED to treat dry eye include artificial tears, calf serum extract, non-steroidal anti-inflammatory drugs, etc. 4. Moderate to severe dry eye requiring treatment with glucocorticoids, immunosuppressants and other drugs; 5. For patients with any systemic disease who are contraindicated to wear contact lenses or who are affected by drug treatment of the disease, common drugs affecting vision include tricyclic depression drugs, phenothiazines, general anesthetics, immunomodulators, etc.; 6. Have a systemic condition that may affect the eye, such as diabetes, Down syndrome, hyperthyroidism, rheumatoid arthritis, a history of sinusitis within 2 years, or other conditions that the investigator considers unsuitable for wearing rigid breathable contact lenses; 7. Patients with a history of ocular trauma or corneal surgery that affected the wearing of contact lenses within one year before enrollment in the study; 8. Abnormal intraocular pressure (intraocular pressure 21 mmHg or binocular pressure difference > 5 mmHg); 9. Both eyes were unsuitable for wearing rigid breathable contact lenses as determined by the researcher Note 3; Note 3: In this clinical trial, the conditions under which rigid breathable contact lenses cannot be worn are: (1) Eyelid abnormality or infection; (2) Clinically significant slit lamp findings (see Annex 4 for details); (3) Other active eye diseases. 10. The fundus examination results did not meet the requirements of Annex 4; 11. The corneal endothelium examination results did not meet the requirements of Annex 4 of the protocol; 12. Those who have worn RGP contact lenses for orthokeratology within 30 days (including participants in clinical trials), those who have participated in clinical trials of contact lenses or care products within 30 days, or those who have participated in other clinical trials at the same time; 13. Candidates who have participated in drug clinical trials within 90 days; 14. Tear film rupture time is less than or equal to 5S; 15. Allergic to contact lenses and/or contact lens care products; 16. Patients with keratoconus or other irregular cornea; 17. Wear rigid breathable contact lenses affected by long-term drying, serious dust, volatile chemicals and other special environments; 18. People who often engage in strenuous exercise, police officers, firefighters and other special professionals; 19. Women who were pregnant, breastfeeding or planning to become pregnant at the time of enrollment; 20. Only one eye meets the requirements for inclusion; 21. Unable to use rigid breathable contact lens as required or unable to conduct regular eye examination; 22. Ineligibility was determined by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| corrected visual acuity;deposit; | — |
Countries
China
Contacts
Public ContactJiang Jun
Eye Hospital of Wenzhou Medical University
Outcome results
None listed