Ametropia
Conditions
Interventions
Treatment group :Wearing orthokeratology lenses manufactured by Hunan Langxing Medical Technology Co., Ltd.
Control group:Wearing orthokeratology lenses manufactured by ABO NORD (Beijing) Medical Technology Co., Ltd.
Sponsors
Eye Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following inclusion criteria to be eligible to participate in this study: 1.Age >= 8 years, regardless of gender; 2.Based on subjective refraction, the refractive error in both eyes must fall within the applicable parameter range of the study lenses (myopia between -6.00D and -4.00D inclusive of -6.00D and exclusive of -4.00D, and astigmatism within 1.50D inclusive); 3.Able to complete a 12-month follow-up and correctly operate and care for the lenses as required during the wear period (for minors, guardians must provide appropriate assistance to complete the operation and care 4.Able to understand the purpose of the trial, voluntarily participate, and sign an informed consent form by the subject themselves or their legal guardian. Note: For minors aged over 8 and under 18, informed consent must be obtained from both the individual and their guardian, and an informed consent form must be signed. For adults aged 18 and over, informed consent must be obtained from the individual themselves, and an informed consent form must be signed.
Exclusion criteria
Exclusion criteria: Subjects with any of the following exclusion criteria in either eye are not eligible for enrollment in this study: 1.One eye meets the inclusion criteria; 2.Has systemic diseases that cause immunosuppression or affect orthokeratology (such as acute or chronic sinusitis within the past year, diabetes, Down syndrome, rheumatoid arthritis, psychiatric disorders, etc.); Has corneal abnormalities, has previously undergone corneal surgery, or has a history of corneal trauma or reduced corneal sensation that the investigator assesses as unsuitable for wearing orthokeratology lenses; 3.Has any of the following ocular conditions: Acute, subacute, or chronic inflammation or infection of the anterior segment; 4. Those with the following eye conditions: 1) Acute, subacute or chronic inflammation and infection of the anterior segment; 2) Any ocular disease, injury or structural abnormality that will affect the cornea, conjunctiva or eyelids, such as dacryocystitis, acute conjunctivitis, blepharitis and other inflammations, glaucoma, etc.; 3) dry eye syndrome (tear film break-up time TBUT <=5 seconds); 4) bacterial, fungal, viral and other active corneal infections; 5) Pathological ocular congestion or redness. 5.Best spectacle-corrected visual acuity in either eye is less than 5.0 (5/100 vision); 6.Corneal flat curvature is less than 39.00D or greater than 48.00D; 7.Refractive error is unstable; 8.Irregular astigmatism; 9.Manifest strabismus; 10.Abnormal intraocular pressure (normal intraocular pressure range is 10–21 mmHg; the difference in intraocular pressure between the two eyes should be less than 5 mmHg); 11.Endothelial cell density of the cornea is less than 2000 cells/mm^2; 12.Has worn orthokeratology lenses within the past 30 days; 13.Has a history of allergy to contact lenses or contact lens care solutions; 14.Is currently using or plans to use medications during the study that may cause dry eyes or affect vision (excluding mydriatics used before vision assessments) and corneal curvature (such as immunosuppressants, corticosteroids, intraocular pressure-lowering medications, etc.); 15.Participated in other drug clinical trials within 90 days prior to screening, or participated in other medical device clinical trials within 30 days; 16.Is pregnant, breastfeeding, or recently planning to become pregnant at the time of enrollment; 17.Cannot follow the ophthalmologist's instructions or attend regular follow-ups; 18.Cannot understand the limitations and reversibility of orthokeratology for myopia correction; 19.Examination results indicate other contraindications for wearing lenses (such as significant epithelial stain on cornea) or unsuitability for wearing orthokeratology lenses; 20.Engages in professions that require maintaining normal vision for extended periods, where it is difficult to rest if vision changes occur; 21.Environmental conditions, hygiene conditions, and working conditions do not meet the wearing requirements for the trial device; 22.Other circumstances determined by the investigator that make the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity and diopter change (subject level); | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected visual acuity and diopter change (Eye count level);Uncorrected visual acuity(UCVA);Subjective refraction;Important parameters of corneal topographic map; | — |
Countries
China
Contacts
Public ContactJiang Jun
Eye Hospital of Wenzhou Medical University
Outcome results
None listed