Effects of atropine eye drops on eye alignment and vision

The Effects of Atropine Eyedrops on Ocular Alignment and Binocular Vision

This study is testing if low doses of atropine eye drops can help children aged 5 to 14 with eye alignment issues and myopia see better and slow down their vision problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 339 (estimated)
• Ages: 5 Years to 14 Years
• Sex: All
• Sponsor: Eye & ENT Hospital of Fudan University (other)
• Locations: 1 site (Shanghai)
• Trial ID: NCT05379855 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are children aged 5 to 14 years with specific types of exotropia or myopia and no significant ocular or systemic health issues.

Not a fit: Patients with amblyopia or those with serious heart or respiratory diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly slow the progression of myopia and improve ocular alignment in affected children.

How similar studies have performed: Previous studies have shown promising results with low concentration atropine in managing myopia, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Shanghai

• Eye and ENT Hospital, Fudan University — Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Lianqun Wu, Doctor

Conditions: Exotropia, Exophoria, Myopia, atropine, myopia, ocular alignment, binocular vision, exotropia