Eye Drops Study for Myopia Control in Schoolchildren
Түлхүүр үгс
Хураангуй
Тодорхойлолт
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.
Огноо
| Сүүлд баталгаажуулсан: | 11/30/2017 |
| Эхлээд оруулсан: | 01/03/2018 |
| Тооцоолсон элсэлтийг оруулсан: | 01/15/2018 |
| Эхлээд нийтэлсэн: | 01/17/2018 |
| Сүүлийн шинэчлэлтийг оруулсан: | 01/15/2018 |
| Сүүлийн шинэчлэлтийг нийтэлсэн: | 01/17/2018 |
| Сургалтын бодит эхлэх огноо: | 10/19/2014 |
| Тооцоолсон анхан шатны ажил дуусах огноо: | 12/30/2019 |
| Судалгааны ажлыг дуусгах өдөр: | 12/30/2019 |
Нөхцөл байдал эсвэл өвчин
Хөндлөнгийн оролцоо / эмчилгээ
Drug: eye drops
Үе шат
Arm Groups
| Гар | Хөндлөнгийн оролцоо / эмчилгээ |
|---|---|
| Experimental: 0.01% atropine children who received 0.01% atropine for myopia | |
| Experimental: 0.005% atropine children who received 0.005% atropine for myopia | |
| Experimental: 0.25% Ketorolac children who received 0.25% Ketorolac for myopia | |
| Experimental: 0.01% atropine plus 0.25% Ketorolac children who received 0.01% atropine plus 0.25% Ketorolac for myopia | |
| Experimental: 0.005% atropine plus 0.25% Ketorolac children who received 0.005% atropine plus 0.25% Ketorolac for myopia |
Эрхийн шалгуур
| Суралцах боломжтой нас | 6 Years Хэнд 6 Years |
| Суралцах боломжтой хүйс | All |
| Эрүүл сайн дурын ажилтнуудыг хүлээн авдаг | Тийм ээ |
| Шалгуур үзүүлэлтүүд | 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 |
Үр дүн
Анхан шатны үр дүнгийн арга хэмжээ
1. Cycloplegic spherical refraction change measured by auto-refractometer (Diopter) [1 year]
2. Axial length change (mm) measured by non-contact biometry [1 year]
Хоёрдогч үр дүнгийн арга хэмжээ
1. Intraocular pressure (mmHg) by non-contact tonometer [1 year]
2. Accommodation (diopter) by accommodometer [1 year]
3. Pupil size (mm) by electronic rule [1 year]
4. Anterior chamber depth (mm) measured by non-contact biometry [1 year]
5. Posterior chamber depth (mm) measured by non-contact biometry [1 year]
Үр дүнгийн бусад арга хэмжээ
1. Questionnaire [1 year]
