rigid gas permeable contact lens wearers
Conditions
Interventions
experimental group:rigid gas permeable contact lens lubricant
control group:Contact lens lubricant
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Age .= 8 years old; 2) The best corrected visual acuity >=5.0 with the degree of double ophthalmoscope within -5.00D (including -5.00D) and the degree of column lens within 1.50D; 3) Able and willing to comply with all treatment and follow-up; 4) Be able to understand the purpose of the experiment, participate voluntarily and have the informed consent signed by the subject himself or his legal guardian.
Exclusion criteria
Exclusion criteria: 1) A single eye meets the inclusion criteria; 2) Have a systemic medical condition that may affect the eyes, such as diabetes mellitus, Down syndrome, hyperthyroidism, rheumatoid arthritis, a history of sinusitis within 2 years, or other medical conditions that are considered unacceptable for wearing a rigid breathable contact lens; 3) Patients with certain eye diseases affecting the wearing of rigid contact lenses, such as acute or chronic eye diseases, catarral conjunctivitis in spring, glaucoma, dry eye (BUT < 5s), corneal abnormalities, etc. 4) Patients with allergic history of contact lens or contact lens solution; 5) Patients who are using or need to use drugs that may cause dry eyes or affect vision and corneal curvature (immunosuppressants, glucocorticoids, intraocular pressure lowering drugs, low concentration atropine) during the study; 6) Patients with a history of internal eye surgery; 7) Patients with abnormal intraocular pressure (normal intraocular pressure ranges from 10 to 21mmHg, and the difference between binocular pressure should be less than or equal to 5mmHg); 8) Participants in clinical trials of other drugs within 90 days and clinical trials of other medical devices within 30 days before screening; 9) Patients who have worn rigid contact lenses (including orthokeratology lenses) within the previous 30 days; 10) Pregnant, lactating or planning to become pregnant at the time of enrollment; 11) Cannot follow the doctor's advice; 12) Patients with contraindications for wearing rigid contact lenses or unsuitable for wearing rigid contact lenses as indicated by examination results; 13) Other conditions for which the investigator judged the patient unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of binocular comfort = Level 3 30 days after wearing glasses;Proportion of optimal corrected visual acuity = 5.0 for both eyes 30 days after wearing glasses; | — |
Secondary
| Measure | Time frame |
|---|---|
| Binocular comfort at 1, 7 and 90 days after hair and wear;The best corrected visual acuity with glasses on both eyes at 1 day, 7 days and 90 days after wearing glasses;Binocular naked eye visual acuity and residual diopter at 1, 7, 30, and 90 days after wearing glasses;Visual acuity in both eyes at 1, 7, 30, and 90 days after wearing glasses;Subjective acceptability evaluation: The subject's acceptability for vision, operability, and lens cleanliness was evaluated at 1, 7, 30, and 90 days after the lens was put on and worn.; | — |
Countries
China
Contacts
Public ContactLongqian Liu
West China Hospital of Sichuan University
Outcome results
None listed