Actively Recruiting

Phase Not Applicable
Age: 5Years - 14Years
All Genders
NCT05379855

A-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

152 weeks

Total Duration

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AI-Summary

What this Trial Is About

Atropine is a non-selective muscarinic acetylcholine (M) receptor antagonist that paralyzes the ciliary muscle, dilates the pupil, and reduces the power of accommodation. Current studies have confirmed the effect of low concentrations of atropine drops in slowing the progression of myopia. In the atropine treatment for myopia (ATOM2) study, there was a rapid and dose-dependent decrease in accommodation after atropine drops: after 2 weeks of use, accommodation decreased from baseline 16.2D to 11.3D (4.9D) in the 0.01% atropine drops group, from baseline 16.7D to 3.8D (12.9D) in the 0.1% atropine group, and from baseline 15.8 D to 2.2 D (13.6 D) in the 0.5% atropine group; one year after withdrawal, there was some recovery of the accommodation in all the three groups, but it was still lower than the baseline values for each group, with a mean decrease of 2.56 D.Similar results were found in the Low-concentration Atropine for Myopia Progression (LAMP) Study by Janson C. Yam, 0.05% atropine drops reduced the accommodation by approximately 2D on average after 1 year of treatment. In general, if accommodation decreases by 2D or more compared to normal values, accommodation insufficiency is considered. There is a linkage between accommodation and convergence called accommodative convergence-to-accommodation (AC/A) which is closely related to exotropia. It was reported that the amount of accommodation required to maintain binocular fusion in patients with intermittent exotropia was greater than that of normal controls. In addition, pupil size and visual acuity are also factors that affect accommodation. In summary, the reduced accommodation amplitude, pupil dilation, and blurred near vision caused by atropine drops would affect the progression of intermittent exotropia and the ocular alignment after the surgery. In most cases, the reduced accommodation and convergence might induce exotropia, but in some patients, they may use more accommodative stimuli to compensate the insufficiency of accommodation, and there may be an increase in convergence or even esotropia. Taken together, due to the effect of atropine drops on pupil size, near visual acuity, and accommodation amplitude, the investigators hypothesize that atropine drops are likely to affect binocular vision and ocular alignment in patients with exotropia and exophoria.

CONDITIONS

Official 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 2.5 diopters, spherical power between -1.00D and -6.00D
  • Difference between eyes in spherical power less than 1.5D
  • Difference between eyes in astigmatism less than 1.00D
  • Intraocular pressure less than 21 mmHg
  • Ocular alignment meeting any of these: Exophoria with near exodeviation more than 6 prism diopters, Intermittent exotropia with exodeviation 25 prism diopters or less at distance and near, Titmus test 400 arc seconds or less
  • For intermittent exotropia patients after strabismus surgery, at least 6 months post-operation and meeting the exophoria and intermittent exotropia criteria above
  • Signed informed consent from subjects and parents or legal guardians, willing to 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 greater than 5 prism diopters, abnormal oblique muscle function 2+ or more, cyclodeviation, DVD or A-V pattern, paralytic or restrictive strabismus, comitant esotropia
  • History of other ocular surgeries
  • Severe complications from strabismus surgery like scleral perforation, extraocular muscle tear or detachment, postoperative eye movement limitation, or decreased visual acuity
  • Other ocular diseases
  • Craniofacial malformations affecting the orbits
  • Significant neurological disorders
  • Birth before 34 weeks of gestation or birth weight less than 1500 grams
  • Intraocular pressure above 21 mmHg
  • Inability to cooperate with examinations

AI-Screening

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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

CONTACT

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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