Emmetropia
Conditions
Interventions
Gold Standard:The study uses "cycloplegic refraction" as the gold standard for diagnosing the true refractive status of children.
Index test:Non-cycloplegic refraction (small-pupil refraction) and cycloplegic refraction (dilated refraction) measurements, axial length (AL), anterior chamber depth (ACD), lens thickness (LT), etc.
Sponsors
Ningbo Eye Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Select study subjects from the EDC system who meet the following criteria: (1) Meet the original project inclusion criteria: primary school students aged 6-12, of any gender; after cycloplegia, refraction confirmed as emmetropia, mild hyperopia, or low to moderate myopia in both eyes (spherical equivalent refraction, SER <= -6.00 D); astigmatism range: -1.50 D <= astigmatism <= 0 D. 2. Select study subjects from the EDC system who meet the following criteria: (2) Have complete examination data: including non-cycloplegic refraction (small pupil refraction), cycloplegic refraction (dilated refraction), IOL Master 700 biometry data, as well as fundus color photographs. 3. Select study subjects from the EDC system who meet the following criteria: (3) Image quality meets requirements: fundus photos without obvious motion artifacts or exposure abnormalities, suitable for subsequent analysis.
Exclusion criteria
Exclusion criteria: (1) Meeting original project exclusion criteria: 1. Patients with anisometropia (difference in refraction between both eyes >=1.00D); 2. Patients with photosensitivity; 3. Patients with a family history of high myopia in parents; 4. Patients with strabismus, amblyopia, keratoconus, glaucoma, cataract, ptosis, active periocular or ocular inflammation (e.g., blepharitis, infectious conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis), or fundus lesions affecting vision; 5. Patients with systemic conditions that may affect refractive development (e.g., Down syndrome, Marfan syndrome); 6. Patients with allergic constitution, systemic diseases or wasting diseases, immune deficiencies, combined with severe primary cardiovascular, liver, kidney, hematopoietic system diseases, immune system diseases, or psychiatric disorders; 7. Patients who underwent ocular surgery within 4 weeks before screening, or plan to undergo ocular surgery within 6 months after enrollment; 8. Patients planning to use orthokeratology lenses, rigid contact lenses, or multifocal progressive lenses for vision correction within 6 months after enrollment; 9. Patients who participated in other drug clinical trials within 3 months before screening; 10. Patients deemed unsuitable for clinical trial participation by the investigator. (2) Orthokeratology lens wearers. (3) Missing key data >20%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cycloplegic spherical equivalent refraction (post-cycloplegic SER);Cycloplegic sphere power;Cycloplegic cylinder power;Prediction error drift (longitudinal validation only); | — |
Secondary
| Measure | Time frame |
|---|---|
| One-year axial length elongation;Optic disc ovality index;Subgroup prediction performance metrics;White-to-white distance (WTW);Axial length to corneal radius ratio (AL/CR);Anterior chamber depth (ACD);Proportion of clinically acceptable predictions;Feature importance score;Bland-Altman 95% limits of agreement;Mean absolute error (MAE);Pearson correlation coefficient (r);Lens thickness (LT);Coefficient of determination (R2);Anterior lens surface radius of curvature;Root mean square error (RMSE);Model calibration;Follow-up interval;Mean keratometry (mean K);Non-cycloplegic spherical equivalent refraction (small-pupil SER);Sex;Axial length (AL);Tessellated fundus grading;Mean prediction bias;Age;Non-cycloplegic sphere power;Corneal astigmatism;Non-cycloplegic cylinder power;One-year change in cycloplegic spherical equivalent refraction;Body mass index (BMI);Peripapillary atrophy (PPA);Colour fundus photograph;Lens thickness to anterior chamber depth ratio (LT/ACD); | — |
Countries
China
Contacts
Public ContactLi Dan
Ningbo Eye Hospital
Outcome results
None listed