refractive error
Conditions
Interventions
test group:Keratoplasty lenses
control subjects:Keratoplasty lenses
Sponsors
Tianjin Eye Hospital/Fudan University Eye, Ear, Nose and Throat Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age = 8 years old, gender is not limited; 2. The refractive range of the contact lenses in both eyes is within the applicable parameters of the study lenses (myopia within -4.00D~-6.00D (excluding -4.00D and including -6.00D) and astigmatism not exceeding 1.50D; 3. Be able to complete the 12-month follow-up visit, and be able to properly operate and care for the lenses as required during the wearing period; 4. Understand the purpose of the test, participate voluntarily and sign the informed consent form by the subject or his/her legal guardian.
Exclusion criteria
Exclusion criteria: 1One eye meets the inclusion criteria; 2Patients with systemic diseases that cause immunocompromise or have influence on corneal reshaping (e.g., acute or chronic Sinusitis (within 2 years), diabetes, Down's syndrome, rheumatoid arthritis, mental illness, etc.). etc.); Patients with corneal anomalies, previous corneal surgery, or a history of corneal trauma or corneal hyperacuity, Patients with corneal epithelial defects; Patients with the following conditions in the eye: -Acute, subacute or chronic inflammation, infection of the anterior segment of the eye; -Any ocular disorder, injury, or structural abnormality that would affect the cornea, conjunctiva, or eyelids, such as lachrymatorrhoea, Acute conjunctivitis, abnormal intraocular pressure, blepharitis, uveitis and other inflammatory diseases, glaucoma and lacrimal diseases. Diseases of the lacrimal apparatus, etc; -Dry eye (tear film break-up time TBUT = 5 seconds); -Bacterial, fungal, viral and other active corneal infections; -Pathological eye congestion or redness. Patients with best-corrected distance visual acuity of less than 5.0 (5-point visual acuity) in either eye; 6. Corneal flat curvature not between 39.00D~48.00D; Patients with unstable refraction; Patients with irregular corneal astigmatism; 9. Patients with dominant strabismus; 10, patients with abnormal intraocular pressure (normal intraocular pressure ranges from 10 to 21mmHg, and the difference in intraocular pressure between both eyes should be less than 5mmHg). 5mmHg) patients; 11, Patients with corneal endothelial cell density <2000 cells/mm²; 12. Patients who have worn keratoplasty lenses within the previous 30 days; 13, Patients with a history of allergy to contact lenses or contact lens care solution; 14. Patients who are using, or need to use during the planned study that may cause dry eyes or affect vision (except for astigmatizing medications used prior to vision screening). Patients who are using or plan to use drugs that may cause dry eyes or affect vision (except for dilating drugs used before vision screening) and corneal curvature (immunosuppressants, glucocorticoids, hypotensive drugs, etc.) Patients who need to use drugs that may cause dry eyes or affect vision (except for dilating drugs used before the visual examination) and corneal curvature (immunosuppressants, glucocorticoid hormones, intraocular pressure-lowering drugs) during the planned study period 15. Participating in other drug clinical trials within 3 months and other medical device clinical trials within 30 days prior to screening. Those who participate in other drug clinical trials within 3 months and other medical device clinical trials within 30 days before screening; Those who are pregnant, breastfeeding or planning to become pregnant at the time of enrollment; 17. Those who are unable to follow the ophthalmologist's instructions or regular follow-up visits; Those who cannot understand the limitation and reversibility of myopia correction by keratoplasty; 19. Examination results suggest that there are other contraindications for wearing keratoplasty lenses (such as obvious fluorescent staining of corneal epithelium) or that they are not suitable for wearing keratoplasty lenses. Patients who are not suitable to wear keratoplasty lenses; Patients who are unable to manage their own hygiene and cannot meet the hygienic conditions required for the use of plastic lenses. Or in the case of minors, the guardian cannot provide appropriate as
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Naked eye vision; | — |
Secondary
| Measure | Time frame |
|---|---|
| Refractionyes ; | — |
Countries
CHINA
Contacts
Public Contactbaoguang.jiang
Fulo(SHANGHAI)MEDICAL INSTRUMENT Co., LTD.
Outcome results
None listed