myopia
Conditions
Interventions
Test group:Orthokeratology lenses (FO)
Control group:Orthokeratology lenses (NOR)
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Age greater than or equal to 8 years old, and any gender; 2.In the subjective refraction examination, the degree of myopia of the subjects in both eyes is between -0.75D to -4.00D (including -0.75 D and -4.00D) and the degree of astigmatism is within 1.50D (including 1.50D); 3.Able to complete 12-month follow-up; 4.Able to understand the purpose of the trial voluntarily and signed the informed consent form by himself or his legal guardian.
Exclusion criteria
Exclusion criteria: 1.Monocular meets inclusion criteria 2.Those who suffer from systemic diseases that cause immunocompromised or have an impact on orthokeratology (such as diabetes, Down syndrome, rheumatoid arthritis, mental illness, etc., acute and chronic sinusitis within 1 year, etc.) 3.Patients with corneal abnormalities, received corneal surgery or have corneal trauma history, corneal hypoesthesia; 4.Those who have the following symptoms in the eyes: ?Bacterial, fungal, viral and other active corneal infections, ?Acute, subacute, or chronic inflammatory infections of the anterior segment other than the cornea, such as acute conjunctivitis, blepharitis, ?Any ocular disease injury or structural abnormality that affects the cornea, conjunctiva or eyelids, such as dacryocystitis, glaucoma, ?Keratoconjunctivitis sicca(Fluorescein Breakup Time(FBUT)=5 s or Schirmer ? test(no anesthesia)=5 mm/5 min) , ?Corneal staining = grade 2, ?Unexplained pathological eye congestion or redness above. 5.Best corrected distance visual acuity less than decimal vision of 5.0; 6.The corneal flat curvature (measured by the corneal curvature meter) is below 40.00D or above 46.00D; 7.Unstable diopter; 8.Irregular corneal astigmatism; 9.Overt strabismus; 10.Intraocular pressure abnormalities (normal intraocular pressure range of 10-21 mmHg binocular intraocular pressure should be less than 5 mmHg); 11.The density of corneal endothelial cells is less than 2000 cells/mm2; 12.Those who have worn orthokeratology lenses in the past 30 days; 13.Those who have a history of allergy to contact lenses or contact lenses care solution; 14.Those who have used dry eye therapeutics within 1 month prior to screening, as well as drugs that may affect the wearing of test products, cause dry eyes, affect vision and corneal curvature, or alter normal eye physiology (immunosuppressants, glucocorticoids, IOP-lowering drugs, therapeutic mydriasis, etc.) that are in use or during the study; 15.Those who have participated in other drug clinical trials within 3 months before screening and who have participated in other medical device clinical trials within 30 days (if the medical device clinical trial participated in is a soft contact lens clinical trial, only those who have participated in a soft contact lens clinical trial within 1 week are excluded)) 16.Those who is breastfeeding or recently planning to become pregnant at the time of enrollment; 17.Those who cannot understand the limitations and reversibility of orthokeratology to correct myopia; 18.Examination results suggest that there are other contraindications to wearing or that they are not suitable for wearing orthokeratology lenses; 19.Other circumstances that the investigator judged is not appropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Acuity;Residual Refraction;Diopter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Product efficiency when wearing glasses for 30 days;Visual Acuity; | — |
Countries
China
Contacts
Public ContactJun Jiang
Eye Hospital, Wenzhou Medical University
Outcome results
None listed