Eye Drops Study for Myopia Control in Schoolchildren

Myopia, Progressive Clinical Trial

Official title:

Eye Drops Study for Myopia Control in Schoolchildren

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03402100
• Other study ID #: 103-3476A3
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2018
• Last updated: January 16, 2018
• Start date: October 20, 2014
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2017
• Source: Chang Gung Memorial Hospital
• Contact: Pei-Chang Wu, MD
• Email: wooopc[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Atropine Allergy
• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

Drug:
• eye drops
children who received daily eye drops for myopia

Locations

Country	Name	City	State
Taiwan	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire	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)	1 year
Primary	Cycloplegic spherical refraction change measured by auto-refractometer (Diopter)	Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) is the main indicator of the myopia progression.	1 year
Primary	Axial length change (mm) measured by non-contact biometry	Axial length change (mm) measured by non-contact biometry is another indicator of the myopia progression.	1 year
Secondary	Intraocular pressure (mmHg) by non-contact tonometer	measures Intraocular pressure (mmHg) by non-contact tonometer	1 year
Secondary	Accommodation (diopter) by accommodometer	Accommodation change (diopter) by accommodometer is another indicator of the myopia progression.	1 year
Secondary	Pupil size (mm) by electronic rule	measures Pupil size (mm) by electronic rule	1 year
Secondary	Anterior chamber depth (mm) measured by non-contact biometry	measures Anterior chamber depth (mm) measured by non-contact biometry	1 year
Secondary	Posterior chamber depth (mm) measured by non-contact biometry	measures Posterior chamber depth (mm) measured by non-contact biometry	1 year