Myopia, Progressive, Atropine Allergy
Conditions
Keywords
myopia, schoolchildren, atropine, allergy, eye drops, outdoor, near work
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.
Interventions
DRUGeye drops
children who received daily eye drops for myopia
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
No
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 * cataract * glaucoma * any ocular diseases ocular surgery * history of systemic diseases (ex. asthma, heart disease...) * contact lenses user * orthokeratology user
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Accommodation (diopter) by accommodometer | 1 year | Accommodation change (diopter) by accommodometer is another indicator of the myopia progression. |
| Pupil size (mm) by electronic rule | 1 year | measures Pupil size (mm) by electronic rule |
| Posterior chamber depth (mm) measured by non-contact biometry | 1 year | measures Posterior chamber depth (mm) measured by non-contact biometry |
| Anterior chamber depth (mm) measured by non-contact biometry | 1 year | measures Anterior chamber depth (mm) measured by non-contact biometry |
| Intraocular pressure (mmHg) by non-contact tonometer | 1 year | measures Intraocular pressure (mmHg) by non-contact tonometer |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire | 1 year | Record by patients and their parents about how many hours per week of near work (ex. computer/video game,cell phone,reading, piano playing...) and outdoor activities, the compliance of atropine use, discomfort after atropine use (ex. photophobia or blurred vision when near work) |
Countries
Taiwan
Contacts
Primary ContactPei-Chang Wu, MD
Outcome results
None listed