Study on the Effect of Two Ways of Cycloplegia on Biological Parameters of Ciliary Muscle

Phase

Condition

Eye Disorders/infections

Myopia

Treatment

N/A

Clinical Study ID

NCT05449015

2022SQ006

Ages 3-12
All Genders

Study Summary

Atropine has a ciliary muscle-paralysing effect and causes hyperopic drift. Besides, atropine has been proven to slow the progression of myopia. Many studies have suggested that atropine can increase the thickness of the choroid. However, few studies have discussed changes in the ciliary muscle after treatment with atropine or other cycloplegic agents.

This study aimed to assess the difference in ciliary muscle morphology before and after two different cycloplegic agents and to analyze the correlation between the changes of ciliary muscle biological parameters and the changes of eye axis, spherical equivalent, lens diopter, choroidal thickness, etc. One hundred and forty-four children would be randomly assigned 1:1 to the 1% atropine group and the tropicamide group. This study might provide clinical evidence for the role of regulatory factors in the occurrence and development of myopia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

①Age 3 to 12 years old;
Astigmatism <2.00D, binocular anisometropia <3.00D, and the best correcteddistance visual acuity is at least 0.8, near vision at least 0.8;
A clear anterior segment image can be obtained through anterior segment OCT;
Have normal thinking and language communication skills, and canactively cooperate with the inspection process; ⑤ No contraindicationsto atropine treatment such as acute eye inflammation, dry eye,keratoconus, diabetes, etc.; ⑥Written informed consent of the guardianand the child himself

Exclusion

Exclusion Criteria:

① Combined with neurological diseases and have allergies or contraindications tocycloplegic drugs or other drugs;
Intraocular pressure ≥21mmHg; history of photosensitivity, glaucoma, blue eyesyndrome, ocular hypertension, and retinal macular lesions or damage;
Patients with chronic eye diseases such as ocular trauma and allergicconjunctivitis;
Those who wear contact lenses and those who use myopia control-relateddrugs within 1 month; ⑤ Patients with previous varus trichiasis, severehorn, conjunctiva infection and other eye diseases;
Insufficient image quality, such as inconsistent field of view,poor image exposure, inaccurate image focus, stains, shadows orcrescent shadows, etc.;
There are systemic diseases; ⑧ Epilepsy, mental disordersunable to communicate normally; ⑨ Other circumstances judgedby the investigator to be unsuitable to participate in theresearch

Study Design

December 22, 2020

June 30, 2023

Study Description

The ciliary muscle exhibited an inward-forward contraction during accommodation, resulting in a significant thickening of the anterior area of the ciliary muscle. In addition to ultrasound biomicroscope (UBM), anterior segment optical coherence tomography (AS-OCT) is also commonly used to study morphological changes in the ciliary muscle. Studies using AS-OCT revealed that the posterior area of the ciliary muscle thinned during accommodation.

The morphology of the ciliary muscles differs in individuals with refractive errors. Many researchers found that the ciliary muscle became thicker with an increase of axial length (AL) Some studies suggested that myopia primarily affected the posterior area of the ciliary muscle.

Connect with a study center

Shanghai Eye Diseases Prevention & Treatment Center
Shanghai, Shanghai 200080
China
Active - Recruiting

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