Status:
RECRUITING
A-eyedrops on Ocular Alignment and Binocular Vision
Lead Sponsor:
Eye & ENT Hospital of Fudan University
Conditions:
Exotropia
Exophoria
Eligibility:
All Genders
5-14 years
Phase:
NA
Brief 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 confirme...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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);
- No binocular vision;
- Combined with vertical strabismus≥5PD, abnormal oblique muscle function≥ 2+, cyclodeviation, DVD or A-V pattern, paralytic and restrictive strabismus, comitant esotropia；
- Previous history of other ocular surgery;
- Severe complications during or after strabismus surgery, such as perforation of the sclera, tear and detachment of extraocular muscle; postoperative eye movement limitation; visual acuity decreased after operation;
- Combined with other ocular diseases;
- Craniofacial malformations affecting the orbits;
- significant neurological disorders;
- Birth less than 34 weeks or birth weight less than 1500 g;
- Intraocular pressure \> 21mmhg;
- Unable to cooperate with the examination.
Key Trial Info
Start Date :
March 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
339 Patients enrolled
Trial Details
Trial ID
NCT05379855
Start Date
March 2 2024
End Date
February 1 2027
Last Update
February 25 2025
Active Locations (1)
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1
Eye and ENT Hospital, Fudan University
Shanghai, China