Eye Drops Study for Myopia Control in Schoolchildren
- Conditions
- Myopia, ProgressiveAtropine Allergy
- Interventions
- Drug: eye drops
- Registration Number
- NCT03402100
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 150
- Myopia diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
- Must be able to use eye drops
- astigmatism -1.50 D or greater
- strabismus
- amblyopia
- cataract
- glaucoma
- any ocular diseases ocular surgery
- history of systemic diseases (ex. asthma, heart disease...)
- contact lenses user
- orthokeratology user
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.01% atropine eye drops children who received 0.01% atropine for myopia 0.005% atropine plus 0.25% Ketorolac eye drops children who received 0.005% atropine plus 0.25% Ketorolac for myopia 0.25% Ketorolac eye drops children who received 0.25% Ketorolac for myopia 0.01% atropine plus 0.25% Ketorolac eye drops children who received 0.01% atropine plus 0.25% Ketorolac for myopia 0.005% atropine eye drops children who received 0.005% atropine for myopia
- Primary Outcome Measures
Name Time Method Axial length change (mm) measured by non-contact biometry 1 year Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.
Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) 1 year Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.
- Secondary Outcome Measures
Name Time Method Pupil size (mm) by electronic rule 1 year measures Pupil size (mm) by electronic rule
Intraocular pressure (mmHg) by non-contact tonometer 1 year measures Intraocular pressure (mmHg) by non-contact tonometer
Anterior chamber depth (mm) measured by non-contact biometry 1 year measures Anterior chamber depth (mm) measured by non-contact biometry
Posterior chamber depth (mm) measured by non-contact biometry 1 year measures Posterior chamber depth (mm) measured by non-contact biometry
Accommodation (diopter) by accommodometer 1 year Accommodation change (diopter) by accommodometer is another indicator of the myopia progression.
Trial Locations
- Locations (1)
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan