Myopia ProgressionNCT02130167
Low Concentration Atropine for Myopia Progression in School Children
A study testing Atropine in people with Myopia Progression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia Progression
- What is being tested?
- Atropine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Aug 2017
- Phase
- Interventional
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.
Who cannot join
- strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Concentrations of Atropine for Controlling Myopia Progression in School Children
Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.
- Conditions
- Myopia Progression
- Being tested
- Atropine
- Keywords
- Myopia progression, Low concentration atropine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtropineDrug
Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine
| Study group | Role | What they receive |
|---|---|---|
| 0.01% Atropine | Experimental | Not described Receives: Drug: Atropine |
| 0.05% Atropine | Active comparator | Not described Receives: Drug: Atropine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic spherical refraction change
Cycloplegic spherical refraction change is the main indicator of the myopia progression.
Measured: 1 year
Secondary outcomes (1)
Axial length change
Axial length change is another indicator of the myopia progression.Using non-contact biometry. unit: millimeter(mm)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2014 (estimated)
- Study startAug 2012
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia ProgressionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Chang Wu, MD,PhD, Principal investigator, Dep. of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02130167
- Sponsor's protocol ID
- CMRPG8C0601
- Status last verified
- Jan 2018
- First submitted
- 28 Apr 2014
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Concentrations of Atropine for Controlling Myopia Progression in School Children
- ClinicalTrials.gov ID
- NCT02130167
- Acronym / sponsor ID
- CMRPG8C0601
- Conditions
- Myopia Progression
- Keywords
- Myopia progression, Low concentration atropine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 5 May 2014 (estimated)
- 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.
Myopia is the leading cause of blindness in Taiwan. The younger children with myopia, the higher risk of high myopia in later life and complications such as retinal detachment and maculopathy will occur. We have reported the low concentration of atropine (0.05%) with the effect on retarding the myopia progression. Recently the 0.01% atropine was also reported effective and with less visual side effects such as mydriasis. The aim of this study is to compare the efficacy in controlling myopia progression and visual side effects of 2 low concentration of atropine(0.05% vs 0.01%) in children aged 6-12 years with myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.01% Atropine | Experimental | Drug: Atropine |
| 0.05% Atropine | Active comparator | Drug: Atropine |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Myopia of at least -0.5 diopters (D) and astigmatism of -1.50 D or less.
Key exclusion criteria (1 listed)
- strabismus, amblyopia. cataract, glaucoma or any ocular diseases ocular surgery history systemic diseases (ex. asthma, heart disease...)
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 |
|---|---|---|
| AtropineCompare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine | Drug | 0.01% Atropine, 0.05% Atropine |
Primary outcome
Cycloplegic spherical refraction change
Time frame: 1 year
Cycloplegic spherical refraction change is the main indicator of the myopia progression.
1 secondary outcome
Axial length change
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
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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.
Pei-Chang Wu, MD,PhD principal investigator
Dep. of Ophthalmology, Kaohsiung Chang Gung Memorial Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atropine in people with Myopia Progression, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 30 Jan 2018. 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 Taiwan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic spherical refraction change (time frame: 1 year). 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 30 Jan 2018.