Myopia
Conditions
Interventions
Test group:wear 5 mm BOZD ortho-k lenses
Control group:wear 6 mm BOZD ortho-k lenses
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children aged 8 to 12 years old; 2. Cycloplegic spherical refraction of -1.00 to -4.00D, astigmatism <= 1.50 D, less than 1.00 D difference in spherical equivalent between the two eyes, best-corrected distant logMAR visual acuity 0.0 or better in either eye; 3. Subjects can wear ortho-k lenses for eight hours overnight during the study period; 4. Subjects and guardians can understand the purpose of the trial, and both subjects and guardians sign the informed consent form. Subjects will be able to cooperate with visits and relevant examination.
Exclusion criteria
Exclusion criteria: 1. Either eye had a narrow anterior chamber angle and shallow anterior chamber at the time of screening; 2. IOP > 21 mmHg in either eye at the time of screening; 3. Tear film break time (BUT) <5 s in either eye at the time of screening; 4. Corneal endothelial cell density less than 2000 cells/mm2 in either eye at the time of screening; 5. Current or past history of manifest strabismus (including intermittent strabismus), amblyopia, or binocular visual function abnormalities; 6. Current or past history of any systemic disease or syndrome (e.g., Marfan syndrome, etc.) that may contribute to severe myopia; 7. Any current or past medical history of ocular disease other than refractive error affecting central vision; 8. Subjects with a serious systemic medical history or who are expected to undergo any systemic surgery during the study period and who, in the opinion of the investigator, are not suitable for participation in this study; 9. Any history of internal eye surgery, history of strabismus surgery, history of refractive surgery; and subjects who are expected to have such surgery during the study period; 10. Current or past history of myopia control treatment, such as ortho-k lenses, defocusing frames lenses, defocusing soft lenses, multifocal RGP, low concentration atropine drops, etc.; 11. Participation in other clinical trials 30 days prior to screening or expected to participate in other clinical trials during the study period; 12. Subjects who are not expected to comply well with the study protocol during the study period; 13. Allergy to any component of the medication or lens care solution used during the study period; 14. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Visual acuity;Subjective refraction;Objective refraction;Corneal topography;Contrast sensitivity;Ocular aberrations;Visual quality related questionnaire;Anterior ocular health; | — |
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Countries
China
Contacts
Public ContactYue Yan
West China Hospital, Sichuan University
Outcome results
None listed