Astigmatism, myopia, hyperopia
Conditions
Interventions
trial group:Wearing rigid gas scleral contact lenses
control group:Wearing rigid gas permeable contact lenses
Sponsors
Eye hospital of Shandong First Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.The age of people between 8 years old (included) and 55 years old (included), regardless of gender. And under the age of 18, people need the written consent from their guardian. They voluntarily participate in the trial and sign an informed consent form. 2.The best corrected visual acuity for frame glasses is = 4.0 (standard logarithmic visual acuity chart); 3.The diopter of one or both eyes is -25.00 to+25.00 D (including -25.00 D and+25.00 D), or presence of corneal astigmatism. According to the situation of the subjects, if one eye of the subjects meets the inclusion and exclusion criteria, it will be included in the study. If both eyes of the subjects meet the inclusion and exclusion criteria, they will be included in the study.
Exclusion criteria
Exclusion criteria: 1. The density of endothelial cells is less than 2000/mm2 or there is a significant corneal endothelial cell defect; 2. Dry eye syndrome (those with tear film rupture time test results less than 5 seconds); 3.Abnormal intraocular pressure (intraocular pressure21mmHg, or binocular intraocular pressure difference = 5mmHg); 4. Explicit strabismus; 5. Bacterial, fungal, viral and other active corneal infections; 6. People are using drugs that may cause dry eyes, affect the eyeball, affect vision, or affect corneal curvature (such as intraocular pressure lowering drugs); 7.Decreased corneal perception and active corneal lesions; 8.Routine slit lamp microscopy and ophthalmoscopy examination, including corneal diseases, iridocyclitis, chronic uveitis, cataracts, and vitreoretinal related eye diseases or active and progressive diseases (1. vitreous hemorrhage or severe turbidity; 2. retinal vascular diseases; 3. macular diseases; 4. choroidal hemorrhage and inflammatory diseases); 9. Other eye diseases: such as dacryocystitis, eyelid diseases and eyelid abnormalities or infections, eye muscle related diseases, visual pathway diseases, glaucoma (uncontrollable increase in intraocular pressure), and severe traumatic vitreous loss caused by a large amount of vitreous body damage, which the researchers have determined to affect visual recovery and need to exclude; 10. Patients with systemic diseases that cause low immunity (such as acute and chronic sinusitis, diabetes, Down's syndrome, hyperthyroidism, rheumatoid arthritis, psychotic patients, etc. within one year, or other diseases that researchers believe cannot wear rigid contact lenses; 11. Have a history of allergies to contact lenses or contact lens care solutions; 12. Pregnancy, lactation, or planned pregnancy in the near future; 13. After comprehensively considering the corneal parameters, morphological characteristics, and refractive examination results of the examination results, the researchers believe that subjects who cannot wear rigid contact lenses are not eligible; 14. Those who have worn hard corneal contact lenses within 30 days or those who have worn soft hydrophilic contact lenses within 10 days; 15. Those who participate in clinical trials of other drugs three months before screening, and those who participate in clinical trials of other medical devices within 30 days; 16. Cyclops patients; 17. Individuals with strong foreign body sensation and poor compliance cannot seek timely and regular medical treatment as required; 18. Other situations where the researcher determines that the patient is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects whose best corrected visual acuity improved by two or more lines (compared to the best corrected visual acuity of frame glasses) or was greater than or equal to 5.0 (standard logarithmic visual acuity chart) with contact lenses; | — |
Secondary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity with contact lenses; diopter; | — |
Countries
China
Contacts
Public ContactTing Wang
Eye hospital of Shandong First Medical University
Outcome results
None listed