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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Influence of Atropine on Choroidal Thickness

NCT03158142

Myopia

COMPLETED PHASE4

A-eyedrops on Ocular Alignment and Binocular Vision

NCT05379855

Exotropia Exophoria Myopia

RECRUITING NA

The Effects of Low Dose Atropine on Choroidal Thickness

NCT03544827

Myopia

COMPLETED PHASE4

Low Concentration Atropine in the Prevention of Myopia in Children.

NCT05939882

Myopia, Progressive

UNKNOWN NA

Efficacy and Safety of 1% Atropine "5+3" Regimen in Children and Adolescents Controlling Myopia

NCT05448989

Myopia

UNKNOWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Accomodation Refractive Errors Myopia Cycloplegia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1% atropine

1% atropine eye drops, in the conjunctival sac, once a night, for 7 days

Group Type EXPERIMENTAL

1% atropine

Intervention Type DRUG

Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia

tropicamide

tropicamide eye drops, in the conjunctival sac, once every 5 minutes, after 3 consecutive doses, close eyes for 20 minutes

Group Type PLACEBO_COMPARATOR

1% atropine

Intervention Type DRUG

Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

1% atropine

Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* ①Age 3 to 12 years old;

* Astigmatism \<2.00D, binocular anisometropia \<3.00D, and the best corrected distance 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 can actively cooperate with the inspection process; ⑤ No contraindications to atropine treatment such as acute eye inflammation, dry eye, keratoconus, diabetes, etc.; ⑥Written informed consent of the guardian and the child himself

Exclusion Criteria

* ① Combined with neurological diseases and have allergies or contraindications to cycloplegic drugs or other drugs;

* Intraocular pressure ≥21mmHg; history of photosensitivity, glaucoma, blue eye syndrome, ocular hypertension, and retinal macular lesions or damage;

* Patients with chronic eye diseases such as ocular trauma and allergic conjunctivitis;

* Those who wear contact lenses and those who use myopia control-related drugs within 1 month; ⑤ Patients with previous varus trichiasis, severe horn, conjunctiva infection and other eye diseases;

* Insufficient image quality, such as inconsistent field of view, poor image exposure, inaccurate image focus, stains, shadows or crescent shadows, etc.;

* There are systemic diseases; ⑧ Epilepsy, mental disorders unable to communicate normally; ⑨ Other circumstances judged by the investigator to be unsuitable to participate in the research

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No