Eye Drops Study for Myopia Control in Schoolchildren
Overview
- Phase
- Not Applicable
- Intervention
- eye drops
- Conditions
- Myopia, Progressive
- Sponsor
- Chang Gung Memorial Hospital
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Axial length change (mm) measured by non-contact biometry
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Myopia diagnosed with the spherical equivalent refraction at least -0.5 diopter (D)
- •Must be able to use eye drops
Exclusion Criteria
- •astigmatism -1.50 D or greater
- •strabismus
- •amblyopia
- •any ocular diseases ocular surgery
- •history of systemic diseases (ex. asthma, heart disease...)
- •contact lenses user
- •orthokeratology user
Arms & Interventions
0.01% atropine
children who received 0.01% atropine for myopia
Intervention: eye drops
0.005% atropine
children who received 0.005% atropine for myopia
Intervention: eye drops
0.25% Ketorolac
children who received 0.25% Ketorolac for myopia
Intervention: eye drops
0.01% atropine plus 0.25% Ketorolac
children who received 0.01% atropine plus 0.25% Ketorolac for myopia
Intervention: eye drops
0.005% atropine plus 0.25% Ketorolac
children who received 0.005% atropine plus 0.25% Ketorolac for myopia
Intervention: eye drops
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Pupil size (mm) by electronic rule(1 year)
- Intraocular pressure (mmHg) by non-contact tonometer(1 year)
- Anterior chamber depth (mm) measured by non-contact biometry(1 year)
- Posterior chamber depth (mm) measured by non-contact biometry(1 year)
- Accommodation (diopter) by accommodometer(1 year)