Myopia
Conditions
Interventions
experimental group:Ortholens Orthokeratology
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 30 Years
Inclusion criteria
Inclusion criteria: 1. Aged 8-30 years (8 and 30 included), both gender; 2. Be able to understand and sign the informed consent form approved by the ethics committee. Minors under the age of 18 need to be accompanied by parents/guardians who can read and understand the informed consent form and sign it; 3. Be able to learn to use ortho-k lens correctly during the baseline/screening visit, and voluntarily wear ortho-k for research 7 nights a week, no less than 8 hours and no more than 10 hours a night during the study; 4. Subjective refraction is -4.00D to -0.75D, astigmatism not exceeding -1.50D with the rule and not exceeding-0.75 D againest the rule; 5. Willing to comply the schedule of clinical trial visit instructed by the investigator/protocol; 6. The results of eye health examination are regarded as "normal"; 7. The best corrected visual acuity is better than or equal to 0.10 LogMAR (decimal visual acuity 0.8 and above); 8. The central corneal endothelial cell density is >= 2000/mm2.
Exclusion criteria
Exclusion criteria: 1. Women with reproductive potential should be excluded if: (1) Pregnant; (2) Plan to get pregnant during the study period; (3) Lactation period; 2. Irregular cornea, keratoconus or suspected keratoconus (pre-clinical tendency of keratoconus); 3. Ongoing anterior segment infection, inflammation or abnormality, such as keratitis/conjunctivitis blepharitis, and lacrimal duct diseases such as dacryocystitis; 4. The systemic or eye signs or medication history that the investigator judges as unsuitable for orthokeratology; 5. The intraocular pressure is higher than 21mmHg or lower than 10mmHg; 6. After slit lamp examination and evaluation, the researcher thinks that the patient is not suitable for clinical trials; 7. Plan to undergo refractive surgery during the study period; 8. Previous eye surgery; 9. Currently enrolled in other clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visual acuity; | — |
Countries
China
Contacts
Public ContactWei Ruihua
Tianjin Medical University Eye Hospital
Outcome results
None listed