Health Condition 1: H521- Myopia
Conditions
Interventions
Intervention1: Atropine 0.05%: Atropine ophthalmic solution 0.05% one drop instilled in each eye once nightly for myopia control, continued for 12 months
Control Intervention1: Atropine 0.01%: Atropin
Sponsors
Dr monika meena
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children aged 5 to 14 years at the time of enrollment. 2. Baseline cycloplegic SER between minus 1.00 D and minus 6.00 D in each eye. 3. Astigmatism (cylindrical) less than or equal to minus 2.5 D. 4. Best-corrected visual acuity 6 by 9 or better in both eyes. 5. Child and parent or guardian willing to give consent and comply with follow up and treatment.
Exclusion criteria
Exclusion criteria: 1. Prior use of atropine or other myopia control treatments (orthokeratology, multifocal lenses, etc.) in the past 12 months. 2. Ocular diseases other than simple refractive error (e.g., amblyopia, strabismus, glaucoma, uveitis, retinal disease etc). 3. History of ocular surgery, trauma, or systemic/ocular medications affecting refraction. 4. Known allergy or hypersensitivity to atropine or formulation ingredients. 5. Systemic or neurological conditions interfering with compliance or accurate testing. 6. Inability of child or parent to adhere to study schedule or follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change in spherical equivalent refraction (SER) from baseline to 12 months between children treated with 0.05% atropine and those treated with 0.01% atropine. Timepoint: At baseline,1 month,6 month and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The change in axial length (mm) from baseline to 12 months between the two groups. 2.The changes in accommodative amplitude induced by the two concentrations. 3.The incidence and severity of adverse effects (photophobia, near vision blur, allergic reactions, etc.) between 0.05% and 0.01% atropine groups. 4. To explore potential predictors of response. Timepoint: At baseline,1 month,6 month and 12 months | — |
Countries
India
Contacts
Public ContactDr Richa Agarwal
All india institue of medical sciences
Outcome results
None listed