Myopia, ProgressiveNCT03402100
Eye Drops Study for Myopia Control in Schoolchildren
A study testing eye drops in people with Myopia, Progressive and Atropine Allergy, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in children and often associated high myopia in later life. This prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Myopia, Progressive, Atropine Allergy
- What is being tested?
- eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Oct 2014to 31 Dec 2019
- 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 diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
- Must be able to use eye drops
Who cannot join
- astigmatism -1.50 D or greater
- strabismus
- amblyopia
- cataract
- glaucoma
- any ocular diseases ocular surgery
Show all 9Show fewer
- history of systemic diseases (ex. asthma, heart disease...)
- contact lenses user
- orthokeratology user
Trial locations and contacts
1 site in 1 country.
Pei-Chang Wu, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 833
Pei-Chang Wu, MD
About this study
The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in children and often associated high myopia in later life. This prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops.
Read the detailed description
Myopia onset earlier in children who would suffer a high degree of myopia in the future adulthood.and higher risk for retinal detachment, macular degeneration, and even blindness. In Taiwan, myopia macular degeneration is the first place of irreversible blind cause in the elderly. The evidence based medicine shows atropine is the most effective treatment for the progression of myopia so far, but the side effects including photophobia and near blurred vision often disturbing patients and resulting poor compliance and high drop-out rate.
Recently, the studies from Taiwan and Singapore showed that low concentrations of atropine (0.05% or 0.01%) can effectively inhibit the myopia progression, reduce the symptoms of photophobia, and to achieve favorable myopia control. Previous study found that myopia and allergic conjunctivitis and inflammation were related. The investigators designed a prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops. Due to environmental factors such as near work, after school class and outdoor activity are also great associated with myopia, the questionnaires also are collected in this study.
- Conditions
- Myopia, Progressive, Atropine Allergy
- Being tested
- eye drops
- Keywords
- myopia, schoolchildren, atropine, allergy, eye drops, outdoor, near work
- Medical subject headings
- Myopia, Degenerative, Myopia, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye dropsDrug
children who received daily eye drops for myopia
| Study group | Role | What they receive |
|---|---|---|
| 0.01% atropine | Experimental | children who received 0.01% atropine for myopia Receives: Drug: eye drops |
| 0.005% atropine | Experimental | children who received 0.005% atropine for myopia Receives: Drug: eye drops |
| 0.25% Ketorolac | Experimental | children who received 0.25% Ketorolac for myopia Receives: Drug: eye drops |
| 0.01% atropine plus 0.25% Ketorolac | Experimental | children who received 0.01% atropine plus 0.25% Ketorolac for myopia Receives: Drug: eye drops |
| 0.005% atropine plus 0.25% Ketorolac | Experimental | children who received 0.005% atropine plus 0.25% Ketorolac for myopia Receives: Drug: eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.
Measured: 1 year
Axial length change (mm) measured by non-contact biometry
Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.
Measured: 1 year
Secondary outcomes (5)
Intraocular pressure (mmHg) by non-contact tonometer
measures Intraocular pressure (mmHg) by non-contact tonometer
Measured: 1 year
Accommodation (diopter) by accommodometer
Accommodation change (diopter) by accommodometer is another indicator of the myopia progression.
Measured: 1 year
Pupil size (mm) by electronic rule
measures Pupil size (mm) by electronic rule
Measured: 1 year
Anterior chamber depth (mm) measured by non-contact biometry
measures Anterior chamber depth (mm) measured by non-contact biometry
Measured: 1 year
Posterior chamber depth (mm) measured by non-contact biometry
measures Posterior chamber depth (mm) measured by non-contact biometry
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 posted18 Jan 2018
- Study start20 Oct 2014
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopia, ProgressiveStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Chang Wu, MD, Principal investigator, No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03402100
- Sponsor's protocol ID
- 103-3476A3
- Status last verified
- Dec 2017
- First submitted
- 4 Jan 2018
- Last updated
- 18 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eye Drops Study for Myopia Control in Schoolchildren
- ClinicalTrials.gov ID
- NCT03402100
- Acronym / sponsor ID
- 103-3476A3
- Conditions
- Myopia, Progressive, Atropine Allergy
- Keywords
- myopia, schoolchildren, atropine, allergy, eye drops, outdoor, near work
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 18 Jan 2018 (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.
The myopia prevalence in schoolchildren is high in Taiwan. The myopia progression is fast in children and often associated high myopia in later life. This prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops.
Detailed description
Myopia onset earlier in children who would suffer a high degree of myopia in the future adulthood.and higher risk for retinal detachment, macular degeneration, and even blindness. In Taiwan, myopia macular degeneration is the first place of irreversible blind cause in the elderly. The evidence based medicine shows atropine is the most effective treatment for the progression of myopia so far, but the side effects including photophobia and near blurred vision often disturbing patients and resulting poor compliance and high drop-out rate.
Recently, the studies from Taiwan and Singapore showed that low concentrations of atropine (0.05% or 0.01%) can effectively inhibit the myopia progression, reduce the symptoms of photophobia, and to achieve favorable myopia control. Previous study found that myopia and allergic conjunctivitis and inflammation were related. The investigators designed a prospective and randomized study to investigate the effect of myopia control in myopic children with ultra low concentrations of atropine eye drops and/or low concentrations of anti-allergic and inflammatory eye drops. Due to environmental factors such as near work, after school class and outdoor activity are also great associated with myopia, the questionnaires also are collected in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.01% atropine | Experimental | Drug: eye dropschildren who received 0.01% atropine for myopia |
| 0.005% atropine | Experimental | Drug: eye dropschildren who received 0.005% atropine for myopia |
| 0.25% Ketorolac | Experimental | Drug: eye dropschildren who received 0.25% Ketorolac for myopia |
| 0.01% atropine plus 0.25% Ketorolac | Experimental | Drug: eye dropschildren who received 0.01% atropine plus 0.25% Ketorolac for myopia |
| 0.005% atropine plus 0.25% Ketorolac | Experimental | Drug: eye dropschildren who received 0.005% atropine plus 0.25% Ketorolac for myopia |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Myopia diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
- Must be able to use eye drops
Key exclusion criteria (9 listed)
- astigmatism -1.50 D or greater
- strabismus
- amblyopia
- cataract
- glaucoma
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 |
|---|---|---|
| eye dropschildren who received daily eye drops for myopia | Drug | 0.005% atropine, 0.005% atropine plus 0.25% Ketorolac, 0.01% atropine, 0.01% atropine plus 0.25% Ketorolac, 0.25% Ketorolac |
Primary outcome
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)
Time frame: 1 year
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.
Axial length change (mm) measured by non-contact biometry
Time frame: 1 year
Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.
5 secondary outcomes
Intraocular pressure (mmHg) by non-contact tonometer
Time frame: 1 year
Accommodation (diopter) by accommodometer
Time frame: 1 year
Pupil size (mm) by electronic rule
Time frame: 1 year
Anterior chamber depth (mm) measured by non-contact biometry
Time frame: 1 year
Posterior chamber depth (mm) measured by non-contact biometry
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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 contact
Pei-Chang Wu, MD principal investigator
No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye drops in people with Myopia, Progressive and Atropine Allergy, 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 2 inclusion and 9 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 18 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Chang Wu, MD (wooopc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) (time frame: 1 year). The study lists 2 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 18 Jan 2018.