Clinical trial NCT03402100: Eye Drops Study for Myopia Control in Schoolchildren
Official title: Eye Drops Study for Myopia Control in Schoolchildren
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia, Progressive
Atropine Allergy
Keywords: myopia
schoolchildren
atropine
allergy
eye drops
outdoor
near work
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* cataract
* glaucoma
* any ocular diseases ocular surgery
* history of systemic diseases (ex. asthma, heart disease...)
* contact lenses user
* orthokeratology user

Primary outcomes:
measure: Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)
timeFrame: 1 year
measure: Axial length change (mm) measured by non-contact biometry
timeFrame: 1 year
Secondary outcomes:
measure: Intraocular pressure (mmHg) by non-contact tonometer
timeFrame: 1 year
measure: Accommodation (diopter) by accommodometer
timeFrame: 1 year
measure: Pupil size (mm) by electronic rule
timeFrame: 1 year
measure: Anterior chamber depth (mm) measured by non-contact biometry
timeFrame: 1 year
measure: Posterior chamber depth (mm) measured by non-contact biometry
timeFrame: 1 year
Other outcomes:
measure: Questionnaire
timeFrame: 1 year
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
affiliation: No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C.
name: Pei-Chang Wu, MD
role: PRINCIPAL_INVESTIGATOR
References: