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

Primary Purpose

Accomodation, Refractive Errors, Myopia

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
1% atropine
Sponsored by
Shanghai Eye Disease Prevention and Treatment Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Accomodation

Eligibility Criteria

3 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ①Age 6 to 12 years old;

    • Both eyes are in line with the diagnosis of myopic refractive error and the myopia is 0.25D < myopia spherical lens <6.00D, 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

Sites / Locations

  • Shanghai Eye Diseases Prevention & Treatment CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1% atropine

tropicamide

Arm Description

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

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

Outcomes

Primary Outcome Measures

ciliary thickness parameters
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
ciliary thickness parameters
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
the distance between ciliary muscle apex and scleral spur
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
the distance between ciliary muscle apex and scleral spur
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software

Secondary Outcome Measures

spherical equivalent
spherical equivalent(SE),Diopter(D), measured by subjective optometry
spherical equivalent
spherical equivalent(SE),Diopter(D), measured by subjective optometry
axial length
axial length(AL), millimeter(mm), measured by IOL master
axial length
axial length(AL), millimeter(mm), measured by IOL master

Full Information

First Posted
June 28, 2022
Last Updated
January 1, 2023
Sponsor
Shanghai Eye Disease Prevention and Treatment Center
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1. Study Identification

Unique Protocol Identification Number
NCT05449015
Brief Title
Study on the Effect of Two Ways of Cycloplegia on Biological Parameters of Ciliary Muscle
Official Title
Study on the Effect of Two Ways of Cycloplegia on Biological Parameters of Ciliary Muscle
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2020 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Eye Disease Prevention and Treatment Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Accomodation, Refractive Errors, Myopia, Cycloplegia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
144 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1% atropine
Arm Type
Experimental
Arm Description
1% atropine eye drops, in the conjunctival sac, once a night, for 7 days
Arm Title
tropicamide
Arm Type
Placebo Comparator
Arm Description
tropicamide eye drops, in the conjunctival sac, once every 5 minutes, after 3 consecutive doses, close eyes for 20 minutes
Intervention Type
Drug
Intervention Name(s)
1% atropine
Intervention Description
Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia
Primary Outcome Measure Information:
Title
ciliary thickness parameters
Description
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
before intervention
Title
ciliary thickness parameters
Description
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
immediately after the last intervention
Title
the distance between ciliary muscle apex and scleral spur
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
before intervention
Title
the distance between ciliary muscle apex and scleral spur
Description
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Time Frame
immediately after the last intervention
Secondary Outcome Measure Information:
Title
spherical equivalent
Description
spherical equivalent(SE),Diopter(D), measured by subjective optometry
Time Frame
before intervention
Title
spherical equivalent
Description
spherical equivalent(SE),Diopter(D), measured by subjective optometry
Time Frame
immediately after the last intervention
Title
axial length
Description
axial length(AL), millimeter(mm), measured by IOL master
Time Frame
before intervention
Title
axial length
Description
axial length(AL), millimeter(mm), measured by IOL master
Time Frame
immediately after the last intervention
Other Pre-specified Outcome Measures:
Title
choroidal thickness
Description
choroidal thickness, microns(um), measured by SSOCT
Time Frame
before intervention
Title
choroidal thickness
Description
choroidal thickness, microns(um), measured by SSOCT
Time Frame
immediately after the last intervention
Title
lens thickness
Description
lens thickness(LT), millimeter(mm), measured by IOL master
Time Frame
before intervention
Title
lens thickness
Description
lens thickness(LT), millimeter(mm), measured by IOL master
Time Frame
immediately after the last intervention
Title
lens power
Description
lens power(LP), diopter(D), calculated by Bennett formula
Time Frame
before intervention
Title
lens power
Description
lens power(LP), diopter(D), calculated by Bennett formula
Time Frame
immediately after the last intervention
Title
corneal parameters
Description
central corneal thickness(CTC), micron(um), measured by IOL master
Time Frame
before intervention
Title
corneal parameters
Description
central corneal thickness(CTC), micron(um), measured by IOL master
Time Frame
immediately after the last intervention
Title
retinal thickness
Description
retina thickness, microns(um), measured by SSOCT
Time Frame
before intervention
Title
retinal thickness
Description
retina thickness, microns(um), measured by SSOCT
Time Frame
immediately after the last intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Xu, M.D.
Phone
+86 18621080996
Email
drxuyan_2004@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidong Zou, M.D.
Organizational Affiliation
Shanghai Eye Diseases Prevention Treatment Center
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Eye Diseases Prevention & Treatment Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haidong Zou, M.D.
Phone
021-62717733
Email
zouhaidong@sjtu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yan Xu, M.D.
First Name & Middle Initial & Last Name & Degree
zhaoyu xiang, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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

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