Eye Drops Study for Myopia Control in Schoolchildren

Chang Gung Medical Foundation

Status: Unknown

Conditions: Atropine Allergy; Myopia, Progressive

Treatments: Drug: eye drops

Study type: Interventional

Funder types: Other

Identifiers

NCT03402100

103-3476A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 5 patient groups

0.01% atropine

Experimental group

Description:

children who received 0.01% atropine for myopia

Treatment:

Drug: eye drops

0.005% atropine

Experimental group

Description:

children who received 0.005% atropine for myopia

Treatment:

Drug: eye drops

0.25% Ketorolac

Experimental group

Description:

children who received 0.25% Ketorolac for myopia

Treatment:

Drug: eye drops

0.01% atropine plus 0.25% Ketorolac

Experimental group

Description:

children who received 0.01% atropine plus 0.25% Ketorolac for myopia

Treatment:

Drug: eye drops

0.005% atropine plus 0.25% Ketorolac

Experimental group

Description:

children who received 0.005% atropine plus 0.25% Ketorolac for myopia

Treatment:

Drug: eye drops