Axial myopia
Conditions
Interventions
Combination Therapy Group (Multifocal Defocus Spectacles + 0.01% Atropine):Wear of multifocal defocus spectacle lenses (Asahifuji brand) for >=10 hours per day.
Instillation of one drop of 0.01% atrop
Spectacles-only Group (Multifocal Defocus Spectacles Monotherapy):Wear of multifocal defocus spectacle lenses (Asahifuji brand) for >=10 hours per day. No atropine eye drops are administered.
Atropine-only Group (0.01% Atropine Monotherapy):0.01% atropine sulfate eye drops monotherapy (nightly instillation) with single-vision spectacle correction.
Sponsors
Rugao People's Hospital, Jiangsu Province, China
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Age: Participants are school-aged children and adolescents aged 6 to 14 years. 2. Diagnosis: Confirmed diagnosis of axial myopia under cycloplegic refraction, meeting the following criteria: For ages 6-8: Axial length (AL) >= 23.50 mm. For ages 9-14: Axial length (AL) >= 24.00 mm. Spherical equivalent (SE) between -0.50 and -6.00 diopters (D). 3. Ocular Health: No active ocular diseases; transparent refractive media (cornea, lens, vitreous). General Health: No severe systemic diseases; no history of allergy to the study drug (atropine) or spectacle lens materials. 4. Informed Consent & Compliance: Written informed consent provided by the legal guardian(s) and assent obtained from the child/adolescent participant. Both the participant and guardian must demonstrate good compliance and be willing and able to complete all study visits and examinations for the 12-month follow-up period.
Exclusion criteria
Exclusion criteria: 1. Myopia Type: Diagnosis of non-axial myopia (e.g., refractive myopia). 2. Ocular Comorbidities: Presence of active or significant ocular diseases, including but not limited to keratitis, conjunctivitis, glaucoma, cataract, or fundus pathologies. 3. Prior Myopia Control Interventions: Any history of receiving treatments for myopia control, such as orthokeratology (ortho-k), defocus spectacle/contact lenses, atropine eye drops, or refractive surgery (e.g., LASIK, PRK). 4. Contraindications & Non-compliance: Known contraindications to atropine or hypersensitivity to any components of the study spectacles.Inability or unwillingness to cooperate with required study procedures, such as cycloplegic refraction and axial length measurement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length;Change in Spherical Equivalent (SE);Annual Myopic Progression Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Accommodation Function (Amplitude of Accommodation, Accommodative Facility/Sensitivity);Vergence Function; | — |
Countries
China
Contacts
Public ContactQian Jin
Rugao People's Hospital, Jiangsu Province, China
Outcome results
None listed