Myopia
Conditions
Interventions
Experimental group:Orthokeratology lenses with symmetrical design and asymmetrical design were worn for one month for each eye in the left eye. The order of attachment is determined at random and does
Control group:Wear symmetrically designed orthokeratology lenses for the right eye
Sponsors
Wenzhou Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 8 years old (including 8 years old), male or female; 2. Spherical diopter -1.00DS-5.00DS, astigmatism is not limited; 3. The corneas of both eyes had asymmetric characteristics that could lead to serious deviation of orthokeratology lenses: the asymmetric vector force on the anterior surface of both eyes was more than 35.00, and the direction of the vector force was downward. 4. The best corrected visual acuity (BCVA) of binocular frame lens was greater than 5.0. 5. Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
Exclusion criteria
Exclusion criteria: 1. Need topical ophthalmic medication or any systemic medication that may interfere with orthokeratology lens fitting; 2. The diopter difference >=-1.00 DS; 3. The resultant force of the asymmetric vector on the anterior surface of the cornea was less than 35.00 in both eyes, or the resultant force of the asymmetric vector was greater than 35.00 but the resultant force was upward, or only one eye had the asymmetric feature. 4. Suffers from eye conditions such as, but not limited to: (1) Corneal endothelial cell density 40, or hexagonal cell ratio 2 grade, pterygium, corneal scar, new blood vessel formation or blood vessel shadow from the edge > 1.0mm, etc (4) IOP > 21mmHg or 5mmHg in either eye (5) Others: glaucoma, abnormal corneal sensation, eyelid dysraphism, ptosis, dominant strabismus, cataract, keratoconus, etc. should not be worn by ophthalmologists; 5. Patients with systemic diseases that may affect the eye, such as but not limited to: acute and chronic sinusitis, steatorrhea eczema, severe diabetes mellitus, lupus erythematosus, scleroderma, rheumatoid arthritis and other collagen diseases, psychiatric patients, excessive neuroticism, etc., can not wear according to the judgment of ophthalmologist; 6. Those who are allergic to contact lenses or related care products, or who have had serious adverse reactions to contact lenses; 7. Patients with eye injury or corneal surgery before enrollment in the trial; 8. Wearing contact lenses (including orthokeratology lenses) within 30 days; 9. Have participated in other soft contact lens clinical trials within 30 days, other rigid contact lens clinical trials within 30 days, other orthokeratology clinical trials within 30 days, drug clinical trials or other clinical trials within 3 months; 10. Women who are pregnant or breastfeeding; 11. Living or working environment is not suitable for wearing contact lenses, such as diffuse dust in the air, drugs, aerosols (such as hair spray, volatile chemicals), dust, etc. 12. Do not have the necessary personal hygiene conditions for wearing orthokeratology lenses; 13. Unable to wear orthokeratology lenses as required; 14. Unable to take regular eye examination; 15. The investigator considered it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Center positioning and degree of deviation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wearing glasses is effective;Corneal reshaping lenses for correcting visual acuity;Axial length;Subjective acceptability of subjects' contact lenses; | — |
Countries
China
Contacts
Public ContactYang Ding
Wenzhou Medical University Eye Hospital
Outcome results
None listed