Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.01% atropine | Experimental | children who received 0.01% atropine for myopia |
|
| 0.005% atropine | Experimental | children who received 0.005% atropine for myopia |
|
| 0.25% Ketorolac | Experimental | children who received 0.25% Ketorolac for myopia |
|
| 0.01% atropine plus 0.25% Ketorolac | Experimental | children who received 0.01% atropine plus 0.25% Ketorolac for myopia |
|
| 0.005% atropine plus 0.25% Ketorolac | Experimental | children who received 0.005% atropine plus 0.25% Ketorolac for myopia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eye drops | Drug | children who received daily eye drops for myopia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (mmHg) by non-contact tonometer | measures Intraocular pressure (mmHg) by non-contact tonometer | 1 year |
| Accommodation (diopter) by accommodometer | Accommodation change (diopter) by accommodometer is another indicator of the myopia progression. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pei-Chang Wu, MD | Contact | wooopc@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pei-Chang Wu, MD | No.123,DAPI Rd. Niaosong Dist, Kaohsiung City 83301 Taiwan, R.O.C. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Chang Gung Memorial Hospital | Recruiting | Kaohsiung City | 833 | Taiwan |
Not provided
| ID | Term |
|---|---|
| D047728 | Myopia, Degenerative |
| D009216 | Myopia |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Pupil size (mm) by electronic rule | measures Pupil size (mm) by electronic rule | 1 year |
| Anterior chamber depth (mm) measured by non-contact biometry | measures Anterior chamber depth (mm) measured by non-contact biometry | 1 year |
| Posterior chamber depth (mm) measured by non-contact biometry | measures Posterior chamber depth (mm) measured by non-contact biometry | 1 year |
| D020228 |
| Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |