Myopia
Conditions
Interventions
experimental group:Wear orthokeratology lenses (Mode: O2-Correct)
Sponsors
Affiliated Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Age greater than or equal to 8 years old and less than or equal to 45 years old; (2) The spherical diopter for binocular correction is between -0.50D (inclusive) and -4.00D Within (including), and the best corrected visual acuity for subjective optometry in the left and right eyes is greater than or equal to At 5.0; (3) The degree of astigmatism is within -1.50D (inclusive); (4) Corneal curvature: (38.00D~48.00D); (5) The subject and/or their guardian are able to understand this study and sign informed consent The subject is able to cooperate with treatment and relevant ophthalmic examinations.
Exclusion criteria
Exclusion criteria: (1) In addition to Refractive error, the researchers believe that they cannot wear corneal shaping The use of rigid breathable contact lenses [Note 1]; Note 1: In the validation of this clinical trial, the term 'cannot wear hard corneal shaper' is used The situation of breathable contact lenses is: ? Having corneal abnormalities, having undergone corneal surgery, or having a history of corneal trauma, angle Patients with decreased membrane perception and a history of eye trauma or intraocular surgery; ? People with the following symptoms in the eyes: bacterial, fungal, viral, and other active diseases Corneal infection; Acute, subacute, or chronic inflammation of the anterior segment other than the cornea Symptoms and infections, such as acute Conjunctivitis and blepharitis; Anything that can affect the cornea and lymph nodes Eye diseases, injuries, or structural abnormalities of membranes or eyelids, such as dacryocystitis, glaucomaEye; ? Clinically significant findings of Slit lamp examination: such as Slit lamp examination of corneal fluorescence Light staining = grade 2, ciliary congestion, bulbar conjunctival congestion, maximum reaction of eyelid conjunctiva Zone level, corneal neovascularization>level 1, and other Slit lamp differences Often, patients who have been determined by researchers to affect the wearing of corneal shaping lenses; ? Irregular corneal astigmatism; (2) Tear film rupture time test results less than 5 seconds; (3) Intraocular pressure is not within normal values (21mmHg), or intraocular pressure Difference = 5mmHg; (4) The density of corneal endothelial cells is less than 2000/mm2; (5) Only those who meet the inclusion criteria for one eye; (6) Patients with strabismus; (7) Patients with unstable refractive index; (8) Individuals with allergies to fluorescein sodium, contact lenses, and/or care products; (9) At the time of selection, she was already a pregnant woman, lactating woman, or a person who was planning to conceive Pregnancy testing is required for elderly women; (10) Suffer from systemic diseases that may affect the eyes, such as Sinusitis (1 year Unstable internal condition), diabetes, Down syndrome, hyperthyroidism, rheumatoid Arthritis, or other researchers believe that hard breathability for corneal shaping cannot be worn Contact lens diseases); (11) Wearing rigid breathable contact lenses or rigid contact lenses for corneal shaping within one month Corneal contact lenses, or those who have worn soft hydrophilic contact lenses within a week; And the use of Atropine eye medicine for myopia prevention and control (has been eluted for 1 month or more Except for the period); (12) Using dry eye treatment medication within one month prior to screening, and currently using or During the research period, the need for use may affect the wearing of experimental products and lead to dryness Eye, drugs that affect vision and corneal curvature or change normal ocular physiology, including Artificial tears, Immunosuppressive drug, antibiotics, glucocorticoids and hormones Compound ophthalmic drug therapists with ingredients; And medication for myopia treatment; (13) Participate in drug clinical trials within 3 months before enrollment or within 30 days before enrollment Those who have participated in clinical trials of other medical devices; (14) Those who cannot undergo regular eye examinations; (15) Other situations that the researcher determines are not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity; Residual diopter;Product efficiency when wearing glasses for 30 days;Diopter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity;Best Corrected Vision; | — |
Countries
China
Contacts
Public ContactQu Jia
Affiliated Eye Hospital of Wenzhou Medical University
Outcome results
None listed