AccomodationPhase 4NCT05449015
Study on the Effect of Two Ways of Cycloplegia on Biological Parameters of Ciliary Muscle
A Phase 4 study testing 1% atropine in people with Accomodation and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Accomodation, Refractive Errors, Myopia
- What is being tested?
- 1% atropine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2020to Jun 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Diseases Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200080
Haidong Zou, M.D., 021-62717733, zouhaidong@sjtu.edu.cn
Yan Xu, M.D.
About this study
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.
Read the 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.
- Conditions
- Accomodation, Refractive Errors, Myopia, Cycloplegia
- Being tested
- 1% atropine
- Medical subject headings
- Refractive Errors, Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% atropineDrug
Daily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia
| Study group | Role | What they receive |
|---|---|---|
| 1% atropine | Experimental | 1% atropine eye drops, in the conjunctival sac, once a night, for 7 days Receives: Drug: 1% atropine |
| tropicamide | Placebo comparator | tropicamide eye drops, in the conjunctival sac, once every 5 minutes, after 3 consecutive doses, close eyes for 20 minutes Receives: Drug: 1% atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
ciliary thickness parameters
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
Measured: before intervention
ciliary thickness parameters
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
Measured: immediately after the last intervention
the distance between ciliary muscle apex and scleral spur
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Measured: before intervention
the distance between ciliary muscle apex and scleral spur
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
Measured: immediately after the last intervention
Secondary outcomes (4)
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Measured: before intervention
spherical equivalent
spherical equivalent(SE)，Diopter(D), measured by subjective optometry
Measured: immediately after the last intervention
axial length
axial length(AL), millimeter(mm), measured by IOL master
Measured: before intervention
axial length
axial length(AL), millimeter(mm), measured by IOL master
Measured: immediately after the last intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study start22 Dec 2020
- Primary completionMar 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AccomodationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haidong Zou, M.D., Study director, Shanghai Eye Diseases Prevention Treatment Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05449015
- Sponsor's protocol ID
- 2022SQ006
- Status last verified
- Dec 2022
- First submitted
- 28 Jun 2022
- Last updated
- 4 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effect of Two Ways of Cycloplegia on Biological Parameters of Ciliary Muscle
- ClinicalTrials.gov ID
- NCT05449015
- Acronym / sponsor ID
- 2022SQ006
- Conditions
- Accomodation, Refractive Errors, Myopia, Cycloplegia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1% atropine | Experimental | Drug: 1% atropine1% atropine eye drops, in the conjunctival sac, once a night, for 7 days |
| tropicamide | Placebo comparator | Drug: 1% atropinetropicamide eye drops, in the conjunctival sac, once every 5 minutes, after 3 consecutive doses, close eyes for 20 minutes |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- ①Age 3 to 12 years old;
Key exclusion criteria (6 listed)
- ① Combined with neurological diseases and have allergies or contraindications to cycloplegic drugs or other drugs;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1% atropineDaily application can be used for mydriasis and refraction examination Weekly long-term application can be used to control myopia | Drug | 1% atropine, tropicamide |
Primary outcome
ciliary thickness parameters
Time frame: before intervention
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
ciliary thickness parameters
Time frame: immediately after the last intervention
ciliary thickness parameters, microns(um), photographed by ASOCT and measured by semiautomatic software
the distance between ciliary muscle apex and scleral spur
Time frame: before intervention
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
the distance between ciliary muscle apex and scleral spur
Time frame: immediately after the last intervention
ciliary muscle thickness, microns(um), photographed by ASOCT and measured by semiautomatic software
4 secondary outcomes
spherical equivalent
Time frame: before intervention
spherical equivalent
Time frame: immediately after the last intervention
axial length
Time frame: before intervention
axial length
Time frame: immediately after the last intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haidong Zou, M.D. study director
Shanghai Eye Diseases Prevention Treatment Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 1% atropine in people with Accomodation and Refractive Errors, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Xu, M.D. (+86 18621080996, drxuyan_2004@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ciliary thickness parameters (time frame: before intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2023.