The Effect of 0.01% Atropine Eye Drops on Axial Length and Refraction in Myopic Children Compared to a Control Group

March 3, 2026 updated by: Hina Nadeem, Liaquat National Hospital & Medical College
In this study, atropine 0.01% eye drops will be given to myopic children once at night daily for 6 months as compared to a control group to see the effect on axial length and refraction

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 4-16 years
  • Both genders
  • Myopia of baseline SER of -1.00D or more
  • Astigmatism less than or equal to -2.50D
  • No medical history predisposing severe myopia (e.g., Marfan syndrome, Stickler syndrome, and retinopathy of prematurity), abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, and spherophakia)
  • No history of other vision-threatening ocular diseases or previous intraocular surgery.
  • No current or previous use of atropine or pirenzipine, contact lenses or other forms of treatment that may affect myopia progression.

Exclusion Criteria:

  • Astigmatism ≥ 2.5 D
  • Anisometropia>1 D
  • Best corrected visual acuity < 0.5 (6/12)
  • Prior intraocular surgery
  • Allergy to atropine eye drops
  • Systemic diseases associated with myopia such as Marfan syndrome, Stickler syndrome
  • History of cardiac or significant respiratory diseases
  • Lack of consent for participating in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A
Atropine 0.01% eye drops
Drug: Atropine 0.01% eye drops
Eye drops atropine 0.01% given once nightly to group A for 6 months
No Intervention: Group B
No eye drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in axial length in mm
Time Frame: 6 months
Axial length is measured at the time of recruiting the participants and after the end of study
6 months
Change in refraction in Diopters
Time Frame: 6 months
Refraction is measured at the start of study then after 6 months of study
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liaquat National Hospital & Medical College

Investigators

  • Principal Investigator: Hina Nadeem, MBBS, LNHMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 13, 2025

Primary Completion (Estimated)

April 17, 2026

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LiaquatNHMC atropine

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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