Treatment to prevent the increase in myopia among childre
Phase 3
- Conditions
- Health Condition 1: H521- Myopia
- Registration Number
- CTRI/2023/12/060537
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
5-15 year children with documented myopia progression of =0.5D/year, myopic refractive error -1 D to -6 D, Best corrected visual acuity 6/9 or better in both the eyes.
Exclusion Criteria
Previously on myopia control intervention, history of ocular surgery, anisometropia ( > 1D), high astigmatism ( > -1.5D), children with strabismus, amblyopia, ocular pathology including poor ocular surface, corneal opacities, staphyloma etc., high astigmatism ( > -1.5D), not willing to follow-up/giving consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Spherical Equivalent Refractive errorTimepoint: Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.
- Secondary Outcome Measures
Name Time Method Change in amplitude of accommodationTimepoint: Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.;Change in ocular biometric parameters (axial length, keratometry, Lens power)Timepoint: Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.;Change in pupil sizeTimepoint: Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.;Effect on higher order aberrations, retinal image quality and contrast sensitivityTimepoint: Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.