Myopia with Moderate-to-High Astigmatism
Conditions
Interventions
Diffusion Optics Technology Group:None
Stellest Group:None
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese adolescents and children aged 6 to 15 years old at the time of first wearing target lenses; 2. Diagnosed with myopia combined with astigmatism, dilated spherical equivalent magoscopia (SER) <= -1.00 D, astigmatism within the range of -1.00 D to -4.00 D (or absolute value 1.00 D to 4.00 D) (cylinder); 3. The best corrected visual acuity in both eyes is 0.8 or above; 4. During the target time period (2023.07.01 - 2025.06.30), the first prescription and successful fitting of wear-controlled glasses or Xingqu control defocus glasses as the main myopia control intervention, and the lens luminosity should cover the full correction prescription (including spherical lenses and all astigmatism); 5. Have glasses records and key follow-up visits, complete baseline, 6 months, 12 months, 18 months, and 24 months visit data, including at least ciliary muscle palsy or subpupillary refraction, and axial length measurement data.
Exclusion criteria
Exclusion criteria: 1. Allergy or intolerance to cycloplegic drugs; 2. Other eye diseases that may significantly affect vision, refractive development, or interfere with the effect of lenses (such as: strabismus>15PD, moderate to severe amblyopia (BCVA<0.6), keratoconus, active ocular surface diseases, cataracts, glaucoma, known retinopathy, optic nerve disease, etc.); 3. Use at the same time during the observation period (pre-baseline or post-baseline follow-up period) or switch to other myopia control interventions (such as: low-concentration atropine eye drops, orthokeratology lenses, OK lenses, multifocal soft contact lenses, other brands/types of defocus frame lenses, etc.) during the study period; 4. History of ocular surgery that affects refractive status (including strabismus correction); 5. Missing baseline data or key follow-up data (especially dilated refraction and AL) or incomplete and unreliable records; 6. Poor wearing compliance (according to medical records, the doctor clearly judges or the patient reports that he rarely wears target glasses); 7. Not wearing this type of lens for the first time (i.e. wearing lenses of the same brand before).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in cycloplegic spherical equivalent refraction (SER) from baseline to Month 24; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in cycloplegic SER from baseline to Month 12;Change in non-cycloplegic cylinder power from baseline to Month 24;Change in non-cycloplegic cylinder power from baseline to Month 12;Change in axial length (AL) from baseline to Month 24;Change in axial length (AL) from baseline to Month 12; | — |
Countries
China
Contacts
Public ContactTianwei Qian
Shanghai General Hospital
Outcome results
None listed