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To study the use of atropine(0.01%)eye drops in halting progression of myopia

A prospective randomized interventional open label study to compare the efficacy and safety of atropine 0.01% eye drops in controlling progression of myopia.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024464
Enrollment
250
Registered
2020-04-03
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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: 0.01% Atropine eye drops: Group A patients will be prescribed atropine eye drops 0.01% along with correction of refractive error for 2 year Control Intervention1: 0.5% Carboxy methyl ce

Sponsors

Dr Arvind Kumar Morya
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All patients with age group 05 to 23 years. 2. Gender male and female 3. Best corrected visual acuity should be 6/6 (20/20; LogMAR 0.0) or better in both eyes 4. Spherical equivalent should be equal to or more than -0.25Diopter 5. Both spherical and or cylindrical refraction would be included. Refraction would be based on cycloplegic refraction and subjective acceptance 6. Patients/legal guardian should be willing to use the eye drops on regular compliant basis. 7. Patients/legal guardian should be able to understand and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. History of ocular inflammation or trauma or treatment of refractive error (medical or surgical) 2. Any ocular comorbidity limiting visual assessment, visual improvement. 3. Any type of amblyopia in one or both eyes. 4. Patient lost to follow up within 1 year of the study or not compliant with the treatment advised

Design outcomes

Primary

MeasureTime frame
Primary: To compare the the efficacy and safety of atropine 0.01% eye drops in controlling progression of myopia. Secondary : To evaluate the systemic and ocular side effects of atropine eye drops 0.01% in myopic patients. Timepoint: Change in spherical equivalent at the end of 2 years.

Secondary

MeasureTime frame
To evaluate the efficacy of atropine 0.01% eye drops in arresting the progression of myopiaTimepoint: To evaluate the efficacy of atropine 0.01% eye drops in arresting the progression of myopia at 2 year of therapy

Countries

India

Contacts

Public ContactDr Arvind Kumar Morya

AIIMS JODHPUR

moryaak@aiimsjodhpur.edu.in9812403786

Outcome results

None listed

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