ametropia
Conditions
Interventions
Experimental group:Scleral contact lens
Control group:Rigid air permeable contact lens
Sponsors
Eye Hospital Affiliated to Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Aged between 18 and 65 (including 18 and 65); (2) Both eyes were within -20.00D~+20.00D; (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 informed consent signed by the subject himself or his legal guardian.
Exclusion criteria
Exclusion criteria: (1) Patients with a variety of eye diseases, such as acute or chronic inflammation of the eye, keratoconus, corneal surgery, severe red eye or eye irritation, glaucoma, corneal dysesthesia, corneal epithelial defect, corneal scar, corneal endothelial cell depletion, dry eye, etc., who are judged by researchers to be unable to wear it; (2) Patients with systemic diseases that cause immunosuppression or may affect the wearing of rigid contact lenses; (3) The best corrected far visual acuity at any one glance is less than 5.0 (5 point visual acuity) (1.0 decimal visual acuity); (4) Subjects who have allergic reactions to the ocular surface and ocular appendages that may be aggravated by wearing lenses or using lens care solution; (5) Subjects with a history of allergy to contact lens or contact lens care products; (6) Subjects who are using or need to use drugs that may cause dry eyes or affect vision, corneal curvature, etc.; (7) Subjects who have worn rigid breathable contact lenses for orthokeratology in the past 1 month (8) Subjects who regularly engage in vigorous exercise; (9) It is not suitable to wear rigid mirrors in living or working environment, such as dispersed dust, drugs, aerosol (such as hair spray, volatile chemicals), dust, etc., or in an environment with high pollution and contact with chemical gases for a long time; (10) Participants in clinical trials of other drugs or medical devices within 1 month before screening; (11) Pregnant, lactating or planning to become pregnant in the near future; (12) Other conditions for which the investigator judged the patient unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with corrected visual acuity 5.0 (5 point visual acuity) (minor visual acuity 1.0) in both eyes after 1 week of wearing glasses; | — |
Secondary
| Measure | Time frame |
|---|---|
| Contact lens corrects vision;Contact lens best corrects vision;Subjective acceptability assessment; | — |
Countries
China
Contacts
Public ContactJun Jiang
Eye Hospital Affiliated to Wenzhou Medical University
Outcome results
None listed