MyopiaPhase 4NCT00541177
Study of Myopia Prevention in Children With Low Concentration of Atropine
A Phase 4 study testing atropine and tropicamide in people with Myopia, run by Min-Sheng General Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to test the hypothesis that myopia can be prevented by using a low concentration of atropine eyedrops once a week. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Myopia
- What is being tested?
- atropine and tropicamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2007to Mar 2008
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 7 to 12 years old
- Has pre-myopia (spherical equivalent between +0.50 and -0.75) after cycloplegic refraction.
- Visual acuity of naked eyes are above 0.6.
- Astigmatism is less than -1.0D and anisometropia less than 1.0D.
Who cannot join
- Has tropia, amblyopia, eyelid disease, or ocular problems.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Min-Sheng General Hospital
Taoyuan, Tao-Yuan
About this study
Official title: Pilot Study of Prevention Myopia in Children With Low Concentration of Atropine
The purpose of this study is to test the hypothesis that myopia can be prevented by using a low concentration of atropine eyedrops once a week.
Read the detailed description
The prevalence rate of myopia is rising rapidly in several Asian countries. A prevalence survey conducted in 1995 of 11178 school children in Taiwan were 12 percent for six year old and 84 percent for teenagers 16 o 18 years. Among them, twenty percent were high myopes. While in the United States and Europe the prevalence rate in older adults is 20% to 50%. The rate of progression of myopia is highest in young children, and the average age of stabilization of myopia is approximately 16 years.The onset of myopia may occur at a relatively young age, leading to higher risks of high myopia (myopia at least 6.0 diopters ) in adulthood. High myopia is associated with potentially blinding complications. Therefore, prevention of myopia progression is important in Taiwan, especially in young children.
There is some evidence that atropine eyedrops retard myopia progression in three randomized clinical trials. It is believed that atropine act on muscarinic receptor located in the sclera and through some unknown mechanism retard the elongation rate of axial length. However, the possible long-term side effects such as cataract formation and retinal toxicity, are largely unknown. Photophobia in daily life, accommodation difficulty both decrease the acceptance of atropine usage and compliance.
There are some evidence that the rate of axial elongation of eyeball are different between pre-myopic stage and myopic stage. Therefore, if we can use low concentration of atropine eyedrops before myopia development. Maybe we can prevent abnormal axial length elongation with lower dosage of atropine eyedrops compared with daily use of atropine eyedrops in true myopia stage.
Clinical study was conducted by randomized control trial. 60 school-aged children were recruited ( Age 7 to 12 years ). All with pre-myopia ( spherical equivalent between +0.50 and -0.75 ) after cycloplegic refraction. Visual acuity of naked eyes are above 0.6. None of them had tropia, amblyopia, eyelid disease, ocular problems. The astigmatism was less than -1.0D and anisometropia was less than 1.0D. The children were randomly assigned into two groups by using randomized consent design. The first group use 0.25% atropine once a week. The second group keep traditional treatment using 0.5% tropicamide eyedrop every day. All children had complete ophthalmologic examination before enrollment. Follow-up examinations were performed every 3 months for 12 months duration. These examinations included visual acuity of naked eye. Intraocular pressure, refractive status. The cycloplegic refraction and axial length were measured every 6 months.
- Conditions
- Myopia
- Being tested
- atropine, tropicamide
- Keywords
- prevention myopia
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
atropineDrug
0.25% atropine
tropicamideDrug
0.5% tropicamide
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | use 0.25% atropine once a week Receives: Drug: atropine |
| 2 | Active comparator | use 0.5% tropicamide everyday Receives: Drug: tropicamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
cycloplegic refraction, visual acuity
Measured: one year
Secondary outcomes (1)
axial length
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startApr 2007
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Sheng General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Leon Chih-Kai Liang, MD MMS, Principal investigator, Min-Sheng General Hospital; National Yang-Ming university, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541177
- Sponsor's protocol ID
- IRB960209-3
- Status last verified
- Oct 2007
- First submitted
- 6 Oct 2007
- Last updated
- 10 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Prevention Myopia in Children With Low Concentration of Atropine
- ClinicalTrials.gov ID
- NCT00541177
- Acronym / sponsor ID
- IRB960209-3
- Conditions
- Myopia
- Keywords
- prevention myopia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Min-Sheng General HospitalUniversity, hospital or other
- Study start
- Apr 2007
- Study completion
- Mar 2008 (estimated)
- First posted
- 10 Oct 2007 (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.
The purpose of this study is to test the hypothesis that myopia can be prevented by using a low concentration of atropine eyedrops once a week.
Detailed description
The prevalence rate of myopia is rising rapidly in several Asian countries. A prevalence survey conducted in 1995 of 11178 school children in Taiwan were 12 percent for six year old and 84 percent for teenagers 16 o 18 years. Among them, twenty percent were high myopes. While in the United States and Europe the prevalence rate in older adults is 20% to 50%. The rate of progression of myopia is highest in young children, and the average age of stabilization of myopia is approximately 16 years.The onset of myopia may occur at a relatively young age, leading to higher risks of high myopia (myopia at least 6.0 diopters ) in adulthood. High myopia is associated with potentially blinding complications. Therefore, prevention of myopia progression is important in Taiwan, especially in young children.
There is some evidence that atropine eyedrops retard myopia progression in three randomized clinical trials. It is believed that atropine act on muscarinic receptor located in the sclera and through some unknown mechanism retard the elongation rate of axial length. However, the possible long-term side effects such as cataract formation and retinal toxicity, are largely unknown. Photophobia in daily life, accommodation difficulty both decrease the acceptance of atropine usage and compliance.
There are some evidence that the rate of axial elongation of eyeball are different between pre-myopic stage and myopic stage. Therefore, if we can use low concentration of atropine eyedrops before myopia development. Maybe we can prevent abnormal axial length elongation with lower dosage of atropine eyedrops compared with daily use of atropine eyedrops in true myopia stage.
Clinical study was conducted by randomized control trial. 60 school-aged children were recruited ( Age 7 to 12 years ). All with pre-myopia ( spherical equivalent between +0.50 and -0.75 ) after cycloplegic refraction. Visual acuity of naked eyes are above 0.6. None of them had tropia, amblyopia, eyelid disease, ocular problems. The astigmatism was less than -1.0D and anisometropia was less than 1.0D. The children were randomly assigned into two groups by using randomized consent design. The first group use 0.25% atropine once a week. The second group keep traditional treatment using 0.5% tropicamide eyedrop every day. All children had complete ophthalmologic examination before enrollment. Follow-up examinations were performed every 3 months for 12 months duration. These examinations included visual acuity of naked eye. Intraocular pressure, refractive status. The cycloplegic refraction and axial length were measured every 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: atropineuse 0.25% atropine once a week |
| 2 | Active comparator | Drug: tropicamideuse 0.5% tropicamide everyday |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 7 to 12 years old
- Has pre-myopia (spherical equivalent between +0.50 and -0.75) after cycloplegic refraction.
- Visual acuity of naked eyes are above 0.6.
- Astigmatism is less than -1.0D and anisometropia less than 1.0D.
Key exclusion criteria (1 listed)
- Has tropia, amblyopia, eyelid disease, or ocular problems.
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 |
|---|---|---|
| atropine0.25% atropine | Drug | 1 |
| tropicamide0.5% tropicamide | Drug | 2 |
Primary outcome
cycloplegic refraction, visual acuity
Time frame: one year
1 secondary outcome
axial length
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2007.
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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.
Leon Chih-Kai Liang, MD MMS principal investigator
Min-Sheng General Hospital; National Yang-Ming university, Taiwan
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 atropine and tropicamide in people with Myopia, run by Min-Sheng General 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 4 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: status not confirmed, as of the sponsor's last update on 10 Oct 2007. 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.
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 Leon Chih-Kai Liang, MD MMS (03-3179599 ext. 8333, eye.care@msa.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cycloplegic refraction, visual acuity (time frame: one 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 10 Oct 2007.