Treatment to prevent the increase in myopia among children

Evaluating Interventional Modalities to prevent progression of childhood myopia - NIL

Status

Recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/12/060537

Enrollment

500

Registered

2023-12-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H521- Myopia

Interventions

Intervention1: Atropine 0.01% eye drops: Atropine sulphate 0.01% ophthalmic solution once at night in both eyes for 2 years Intervention2: Atropine 0.05% eye drops: Atropine sulphate 0.05% ophthalmic

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in Spherical Equivalent Refractive errorTimepoint: Baseline (day 0), 2 week, 6 month, 12 month, 18 month and 24 month.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

India

Contacts

Public ContactVinay Gupta

AIIMS New Delhi

rohitsaxena80@yahoo.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026