New Drug trial in prevention of the progression of myopia in Indian children

Safety and efficacy of Atropine 0.01% and 0.05% in prevention of the progression of Myopia in Indian children

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/11/038177

Enrollment

270

Registered

2021-11-22

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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 % and atropine 0.05% eyedrops: prescription of atropine 0.01 % and 0.05 % eye drops once a day in Group A and Group B myopic children Control Intervention1: Carboxy meth

Eligibility

Inclusion criteria

Inclusion criteria: 1 )Age of 5 to 16 years 2 ) Myopia â?? 1D to -6 D 3 )Annual myopic progression of greater than 0.5 D

Exclusion criteria

Exclusion criteria: â?? Refractive Myopia â?? Astigmatism >= 1.5 D â?? Amblyopia â?? Prior intraocular surgery â?? Allergy to atropine eye drops â?? Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome â?? History of cardiac or significant respiratory diseases â?? Lack of consent for participating in the study

Design outcomes

Primary

Measure	Time frame
Quantitative assessment of change in refractive error before and after treatment of different concentrations of atropineTimepoint: 3 , 6 and 12 months	—

Secondary

Measure	Time frame
1) Measurement of axial length before and after treatment of different concentrations of atropine 2 ) Side effects of low concentration of atropine Timepoint: 3 , 6 and 12 months	—

Countries

India

Contacts

Public ContactDr Siddharam S Janti

AIIMS Bibinagar

drsiddharam@gmail.com9962171725

Outcome results

None listed

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