An interventional study of eye drops in Myopia, Progressive and Atropine Allergy, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2018-01-18.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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.
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.
71 studies on the registry are indexed under Myopia, Degenerative; 20 are open to participants now.
This study's planned enrollment of 150 is above the median of 122 across 57 interventional studies indexed under Myopia, Degenerative.
Browse Myopia, Degenerative studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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Exclusion Criteria:
children who received 0.01% atropine for myopia
Drug: eye drops
children who received 0.005% atropine for myopia
Drug: eye drops
children who received 0.25% Ketorolac for myopia
Drug: eye drops
children who received 0.01% atropine plus 0.25% Ketorolac for myopia
Drug: eye drops
children who received 0.005% atropine plus 0.25% Ketorolac for myopia
Drug: eye drops
children who received daily eye drops for myopia
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.
Time frame: 1 year
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.
Time frame: 1 year
Intraocular pressure (mmHg) by non-contact tonometer
measures Intraocular pressure (mmHg) by non-contact tonometer
Time frame: 1 year
Accommodation (diopter) by accommodometer
Accommodation change (diopter) by accommodometer is another indicator of the myopia progression.
Time frame: 1 year
Pupil size (mm) by electronic rule
measures Pupil size (mm) by electronic rule
Time frame: 1 year
Anterior chamber depth (mm) measured by non-contact biometry
measures Anterior chamber depth (mm) measured by non-contact biometry
Time frame: 1 year
Posterior chamber depth (mm) measured by non-contact biometry
measures Posterior chamber depth (mm) measured by non-contact biometry
Time frame: 1 year
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)
Time frame: 1 year
Started Oct 2014 (actual). Primary completion is estimated for Dec 2019, 62 months after the start.
Of 30 interventional studies with no phase under Myopia, Degenerative, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 96. This study's planned 62 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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