Actively Recruiting

Phase Not Applicable
Age: 5Years - 14Years
All Genders
ID05379855

The Effects of Atropine Eyedrops on Ocular Alignment and Binocular Vision

Led by Eye & ENT Hospital of Fudan University · Updated on 2025-02-25

339

Participants Needed

1

Research Sites

N/A

Total Duration

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AI-Summary

What this Trial Is About

Researchers are investigating the effects of low concentration atropine eye drops on ocular alignment and binocular vision in children with exotropia, exophoria, and myopia. Atropine is known to reduce the power of accommodation by paralyzing the ciliary muscle and dilating the pupil, which can impact binocular vision and eye alignment. This trial aims to better understand how atropine influences these factors, especially since myopia and intermittent exotropia often occur together in children, and atropine is widely used to slow myopia progression. Participants will be randomly assigned to one of three groups: 0.05% atropine eye drops, 0.01% atropine eye drops, or placebo eye drops containing 0.1% sodium hyaluronate. Each participant will apply the assigned eye drops to both eyes once every night. The eye drops are prepackaged identically and stored under controlled conditions. This treatment period is planned for up to 2 years, with regular follow-ups to monitor effects. During the study, children will undergo various eye examinations to measure refraction, axial length, stereopsis, fusion, accommodative function, ocular alignment, and other binocular vision parameters at 1 year and 2 years. Researchers will track changes in accommodation amplitude, pupil size, and visual acuity, as well as safety and tolerability. The total participation will last up to 2 years, including regular clinic visits for assessments and monitoring.

CONDITIONS

Brief Title

A-eyedrops on Ocular Alignment and Binocular Vision

Who Can Participate

Age: 5Years - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 5 and 14 years
  • Astigmatism less than 2.5D and spherical power between -1.00D and -6.00D
  • Difference between eyes in spherical power less than 1.5D and in astigmatism less than 1.00D
  • Intraocular pressure less than 21 mmHg
  • Ocular alignment showing exophoria with near exodeviation greater than 6 PD or intermittent exotropia with exodeviation 25 PD or less both at distance and near
  • Intermittent exotropia patients 6 months after strabismus surgery meeting above alignment criteria
  • Participants and guardians willing to sign informed consent and accept randomization and regular follow-up
Not Eligible

You will not qualify if you...

  • Amblyopia
  • Heart disease or serious respiratory disease
  • Allergy to atropine, cyclopentantone, propoxybenzocaine, or benzalkonium chloride
  • Previous use of contact lenses, bifocal lenses, or other myopia control measures including atropine
  • No binocular vision
  • Vertical strabismus 5 PD or more, abnormal oblique muscle function 2+ or more, cyclodeviation, DVD or A-V pattern, paralytic or restrictive strabismus, or comitant esotropia
  • History of other ocular surgery
  • Severe complications from strabismus surgery such as scleral perforation, muscle tear or detachment, postoperative eye movement limitation, or decreased visual acuity
  • Other ocular diseases
  • Craniofacial malformations affecting the orbits
  • Significant neurological disorders
  • Premature birth before 34 weeks or birth weight less than 1500 g
  • Intraocular pressure greater than 21 mmHg
  • Inability to cooperate with examinations

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 2 years

Participants use assigned eye drops (0.01% atropine, 0.05% atropine, or placebo) in both eyes every night to study the effects on ocular alignment and binocular vision.

Regular visits to monitor eye alignment and vision as per study schedule

Trial Site Locations

Total: 1 location

1

Eye and ENT Hospital, Fudan University

Shanghai, China

Actively Recruiting

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Research Team

L

Lianqun Wu, Doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2).

Audrey Chia, Wei-Han Chua, Yin-Bun Cheung...

https://pubmed.ncbi.nlm.nih.gov/21963266

Low-Concentration Atropine for Myopia Progression (LAMP) Study: A Randomized, Double-Blinded, Placebo-Controlled Trial of 0.05%, 0.025%, and 0.01% Atropine Eye Drops in Myopia Control.

Jason C Yam, Yuning Jiang, Shu Min Tang...

https://pubmed.ncbi.nlm.nih.gov/30514630

Clinical exhibition of increased accommodative loads for binocular fusion in patients with basic intermittent exotropia.

Suk-Gyu Ha, Sung-Min Jang, Yoonae A Cho...

https://pubmed.ncbi.nlm.nih.gov/27266700