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Recruiting NCT07456488

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

Phase II Interventional Focus on Axial Length

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Atropine 0.01% eye drops.
Who it may be relevant to
Registry conditions: Focus on Axial Length. Basic parameters: 4 years — 16 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Drug Atropine 0.01% eye drops
    Eye drops atropine 0.01% given once nightly to group A for 6 months

Primary outcome measures

  • Change in axial length in mm [Time frame: 6 months]
  • Change in refraction in Diopters [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Pakistan · 1 center
  • LiaquatNHMC — Karachi

Identifiers

NCT: NCT07456488 · LiaquatNHMC atropine

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗