The Effects of Atropine Eyedrops on Ocular Alignment and Binocular Vision

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 14
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Eye and ENT Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Lianqun Wu, Doctor
wulianqun19@aliyun.com
+8613022110637
Time Frame
Start Date: 2024-03-02
Estimated Completion Date: 2027-02-01
Participants
Target number of participants: 339
Treatments
Experimental: 0.05% atropine group
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℃.
Placebo_comparator: placebo group
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℃.
Experimental: 0.01% atropine group
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℃.
Sponsors
Leads: Eye & ENT Hospital of Fudan University

This content was sourced from clinicaltrials.gov