A-eyedrops on Ocular Alignment and Binocular Vision

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-14
SponsorEye & ENT Hospital of Fudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • 0.01% atropine eye drops

    Drug

    using 0.01% atropine eye drops for both eyes every night

  • placebo eye drops (0.1% sodium hyaluronate ophthalmic solution)

    Drug

    using placebo eye drops (0.1% sodium hyaluronate ophthalmic solution) for both eyes every night

  • 0.05% atropine eye drops

    Drug

    using 0.05% atropine eye drops for both eyes every night

Treatment groups

339 Participants
are divided into 3 treatment groups
Group A: 0.05% atropine groupExperimental treatment 1 intervention
Group B: placebo groupPlacebo comparator 1 intervention
Group C: 0.01% atropine groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Refraction

Change from baseline in spherical equivalent measured using cycloplegic autorefraction

Time frame
1 year and 2 years
2

Axial length

Change from baseline in Axial length measured using Optical Biometer

Time frame
1 year and 2 years

Secondary outcomes

1

Stereopsis

Change from baseline in stereopsis measured with the Random dot stereogram.

Time frame
1 year and 2 years
2

Fusion

Change from baseline in fusion measured with the Worth Four-Dots.

Time frame
1 year and 2 years
3

AC/A ratio

Change from baseline in AC/A ratio measured using the Von Graefe method

Time frame
1 year and 2 years
4

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

Other outcomes

Sponsors and contacts

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