Effects of atropine eye drops on eye alignment and vision

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of low concentration atropine eye drops on ocular alignment and binocular vision in children aged 5 to 14 years with conditions such as exotropia and myopia. Participants will be randomly assigned to receive either 0.01% or 0.05% atropine drops or a placebo, with the aim of assessing the efficacy of atropine in slowing myopia progression and improving eye alignment. The study will monitor changes in accommodation and ocular alignment over a specified period, contributing to understanding the long-term effects of atropine treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* The age ranged from 5 to 14 years;
* Astigmatism \< 2.5D, spherical power: - 1.00D \~ -6.00D; difference between eyes in spherical power \< 1.5D, difference between eyes in astigmatism \< 1.00D;
* Intraocular pressure \< 21mmHg;
* Ocular alignment fulfilling the following criteria：Exophoria with an exodeviation at near \> 6PD12; Intermittent exotropia with an exodeviation ≤25 PD both at distance and at near, Titmus \<=400 arc seconds; Intermittent exotropia patients underwent strabismus surgery, 6 months after operation, fulling the criteria of exophoria and intermittent exotropia mentioned before.
* Subjects and their parents or legal guardians have signed informed consent and are willing to accept randomized grouping and regular follow-up.

Exclusion Criteria:

* Amblyopia
* Have heart disease or serious respiratory disease
* Allergic to atropine, cyclopentantone, propoxybenzocaine and benzalkonium chloride;
* Those who have used contact lenses, bifocal lenses, or other measures to control myopia (including atropine);
* No binocular vision;
* Combined with vertical strabismus≥5PD, abnormal oblique muscle function≥ 2+, cyclodeviation, DVD or A-V pattern, paralytic and restrictive strabismus, comitant esotropia；
* Previous history of other ocular surgery;
* Severe complications during or after strabismus surgery, such as perforation of the sclera, tear and detachment of extraocular muscle; postoperative eye movement limitation; visual acuity decreased after operation;
* Combined with other ocular diseases;
* Craniofacial malformations affecting the orbits;
* significant neurological disorders;
* Birth less than 34 weeks or birth weight less than 1500 g;
* Intraocular pressure \> 21mmhg;
* Unable to cooperate with the examination.

Where it's running

• Eye and ENT Hospital, Fudan University
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Lianqun Wu, Doctor
• Email: wulianqun19@aliyun.com
• Phone: +8613022110637

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.