Myopia
Conditions
Interventions
Control grouo:Subjects will be fitted with + 0.75D conventional compression factor orthokeratology lenses.
Test Group:Subjects will be fitted with + 0.75D conventional compression factor orthokeratology lenses.
Sponsors
West China hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
8 Years to 12 Years
Inclusion criteria
Inclusion criteria: (1) Age between 8 and 12 years old. (2) The best corrected visual acuity in a single eye is no worse than 20/25. (3) Spherical refractive error between -4.00 D and -0.75 D. (4) Corneal astigmatism <= 1.50D, axis at 180±30, subjective refraction astigmatism <= 1.50D. (5) Anisometropia <= 1.00D. (6) No history of myopia control treatment, no history of wearing contact lenses. (7) Able to attend regular follow-up visits to West China Hospital until the lenses have been worn for 12 months. (8) Sleep no less than 8 hours per night, wear lens at least 6 nights per week. (9) Clear optical structure in the examined eye. (10) No nystagmus in the examined eye and good fixation ability (11) Corneal curvature (examined by keratometer) between 39.50 D and 45.00 D.
Exclusion criteria
Exclusion criteria: (1) Single eye meet the inclusion criteria. (2) Suffering from systemic diseases that may affect the eye, such as diabetes, Down's syndrome, hyperthyroidism, rheumatoid arthritis, or other conditions that researchers consider unacceptable for ortho-k lenses. (3) Suffering from ocular disorders that may affect the fitting of ortho-k lens: e.g., vernal keratoconjunctivitis, dry eye disorder (BUT <5s), etc. (4) Suffering from strabismus. (5) Patients who are on or require drugs during the study period that may cause dry eye or affect visual acuity and corneal curvature, etc. (immunosuppressants, glucocorticoids, IOP-lowering medication, low concentrations of atropine). (6) Those who have a history of internal eye surgery. (7) Patients with abnormal intraocular pressure (normal IOP range is 10-21 mmHg, and the difference in bilateral IOP should be =5 mmHg). (8) Those who participated in other drug clinical trials within 90 days prior to screening, and those who participated in other medical device clinical trials within 30 days. (9) Those who cannot be followed up as prescribed by the researchers. (10) Patients whose examination results suggest contraindications to fitting or unsuitability for fitting ortho-k lenses. (11) Other conditions that the researchers consider unsuitable to participate in.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity;Objective refraction;Subjective refraction;Aberration;Specular microscope;Retinal peripheral defocus;Choroidal thickness;Vision-related questionnaire; | — |
Countries
China
Contacts
Public ContactWei Ma
West China Hospital, Sichuan University
Outcome results
None listed