An interventional study of 0.01% atropine eye drops and placebo eye drops (0.1% sodium hyaluronate ophthalmic solution) in Exotropia, Exophoria and Myopia, sponsored by Eye & ENT Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 5 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-02-25.
Sponsored by Eye & ENT Hospital of Fudan University · Not applicable, Interventional, and Treatment
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.
The prevalence of myopia in the world has exceeded 25% and is increasing year by year. Asia, especially China, is an area with high incidence of myopia. It is reported that the prevalence of myopia in children and adolescents in China was 53.6% in 2018. Low concentration atropine eye drops is one of the effective means to slow the progression of myopia. At present, low concentration atropine eye drops have been widely used in China, but its long-term efficacy and possible side effects still need to be studied.
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 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; after 1 year of discontinuation, 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 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, therefore the decrease of accommodation will also affect the binocular vision. Above all, the effect of atropine eye drops on pupil size, near visual acuity, amplitude of accommodation which is still impaired after 1 years' withdrawal, make us have many concerns and doubts about indications of atropine eye drops in children with strabismus or after the strabismus surgery.
Strabismus is a common eye disease in children, with an incidence rate of about 3%. It is reported that about 72% of strabismus cases in Asia are exotropia, of which intermittent exotropia is the most common type, and most cases are accompanied with myopia. It is found that patients with intermittent exotropia are often associated with abnormal accommodation. Ha SG 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 clarity are also factors affecting accommodation. In conclusion, atropine eye drops may affect the occurrence and development of intermittent exotropia by reducing the amplitude of accommodation, dilating pupils and blurred near vision. At the same time, the reduction of accommodation causes poor focusing and inappropriate afferent signals of the convergence system, which will lead to the fatigue of the convergence and divergence system, which may affect the ocular alignment of exotropia after 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.
In general, in China, myopia with exotropia or exophoria is a high incidence of eye disease in children, and low concentration atropine eye drops have been widely used to control the progression of myopia. It is urgent to carry out a large sample randomized controlled clinical trial to evaluate the impact of low concentration atropine on the ocular alignment and binocular vision of patients with exotropia and exophoria, and guide much safer application of the low concentration atropine eye drops.
58 studies on the registry are indexed under Exotropia; 13 are open to participants now.
This study's planned enrollment of 339 is above the median of 50 across 49 interventional studies indexed under Exotropia.
Browse Exotropia studies →Eye & ENT Hospital of Fudan University is the lead sponsor of 126 studies on the registry; 70 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Subjects received 0.05% atropine eye drops (0.1% sodium hyaluronate as a solution) both eyes once every night. Eye drops are prepackaged with identical eye drops bottle, pasted with number and shelf life, and stored in 4℃.
Drug: 0.05% atropine eye drops
Subjects of the control group received placebo eye drops (0.1% sodium hyaluronate ophthalmic solution) both eyes once every night. Eye drops are prepackaged with identical eye drops bottle, pasted with number and shelf life, and stored in 4℃.
Drug: placebo eye drops (0.1% sodium hyaluronate ophthalmic solution)
Subjects received 0.01% atropine eye drops (0.1% sodium hyaluronate as a solution) both eyes once every night. Eye drops are prepackaged with identical eye drops bottle, pasted with number and shelf life, and stored in 4℃.
Drug: 0.01% atropine eye drops
using 0.01% atropine eye drops for both eyes every night
using placebo eye drops (0.1% sodium hyaluronate ophthalmic solution) for both eyes every night
using 0.05% atropine eye drops for both eyes every night
Refraction
Change from baseline in spherical equivalent measured using cycloplegic autorefraction
Time frame: 1 year and 2 years
Axial length
Change from baseline in Axial length measured using Optical Biometer
Time frame: 1 year and 2 years
Stereopsis
Change from baseline in stereopsis measured with the Random dot stereogram.
Time frame: 1 year and 2 years
Fusion
Change from baseline in fusion measured with the Worth Four-Dots.
Time frame: 1 year and 2 years
AC/A ratio
Change from baseline in AC/A ratio measured using the Von Graefe method
Time frame: 1 year and 2 years
Negative and positive relative accommodation
Change from baseline in negative and positive relative accommodation measured using a phoropter.
Time frame: 1 year and 2 years
Fusional convergence and divergence amplitudes
Change from baseline in fusional convergence and divergence amplitudes measured using a phoropter.
Time frame: 1 year and 2 years
Accommodative facility
Change from baseline in accommodative facility measured using flip lens technique.
Time frame: 1 year and 2 years
Accommodative amplitude
Change from baseline in accommodative amplitude measured using the minus lens techniques.
Time frame: 1 year and 2 years
Near point of convergence
Change from baseline in near point of convergence measured using standard push-up technique.
Time frame: 1 year and 2 years
Ocular alignment
Change from baseline in ocular alignment measured by a prism alternating cover test using an accommodative target at 6 m and 1/3 m.
Time frame: 1 year and 2 years
Plan to share: No — The investigators concerns about patient privacy issues and it's better to protect the publication potential.
Started Mar 2024 (actual). Primary completion is estimated for Feb 2027, 34 months after the start.
Of 29 interventional studies with no phase under Exotropia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 34 months is above that.
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Studies of the drug tested here: Atropine
Eye & ENT Hospital of Fudan University →