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| Name | Class |
|---|---|
| Brien Holden Vision | INDUSTRY |
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To assess the two-week ocular responses, especially on pupillary size and accommodative amplitude, of nightly application of 0.01% or 0.02% or 0.03% atropine eye drops in children with myopia who were randomized to use of three different low-concentration atropine eye drops
Atropine was proven to be effective in controlling myopia progression. However, the most common side effects of the use of atropine eye drop are dilation of pupil and decrease of accommodation. The investigators wish to evaluate the ocular responses of three low concentration atropine eye drops, 0.01% or 0.02% or 0.03%, mainly on the pupillary size and accommodative responses in children aged between 6 to 12 years old over two-week usage.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.01% atropine eye drops | Active Comparator | Participants will receive one drop per eye every night for two weeks |
|
| 0.02% atropine eye drops | Active Comparator | Participants will receive one drop per eye every night for two weeks |
|
| 0.03% atropine eye drops | Active Comparator | Participants will receive one drop per eye every night for two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.01% atropine eye drops | Drug | 0.01% atropine sulphate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pupillary diameter | Measure and compare the photopic and mesopic pupil size (milimeters) before and after instillation of eye drops | at baseline, at three day and at two week |
| Change in accommodative amplitude | Measure and compare the accommodative amplitude (diopters) before and after instillation of eye drops | at baseline, at three day and at two week |
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Inclusion Criteria:
Exclusion Criteria:
NB: Systemic antihistamines are allowed on an "as needed basis", provided they are not used prophylactically during the trial and at least 24 hours before the clinical trial product is used.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology - An Sinh Hospital | Ho Chi Minh City | 700000 | Vietnam |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26875007 | Background | Holden BA, Fricke TR, Wilson DA, Jong M, Naidoo KS, Sankaridurg P, Wong TY, Naduvilath TJ, Resnikoff S. Global Prevalence of Myopia and High Myopia and Temporal Trends from 2000 through 2050. Ophthalmology. 2016 May;123(5):1036-42. doi: 10.1016/j.ophtha.2016.01.006. Epub 2016 Feb 11. | |
| 24310242 | Background |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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The study treatments will be labelled as A, B and C by one of the team member who does not involve in the assessment and follow-up. The masked study products will then be sent to the study coordinator to dispense
| 0.02% atropine eye drops |
| Drug |
0.02% atropine sulphate |
|
| 0.03% atropine eye drops | Drug | 0.03% atropine sulphate |
|
| Sankaridurg PR, Holden BA. Practical applications to modify and control the development of ametropia. Eye (Lond). 2014 Feb;28(2):134-41. doi: 10.1038/eye.2013.255. Epub 2013 Dec 6. |
| 26826749 | Background | Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H, Saw SM, Chen H, Bao F, Zhao Y, Hu L, Li X, Gao R, Lu W, Du Y, Jinag Z, Yu A, Lian H, Jiang Q, Yu Y, Qu J. Efficacy Comparison of 16 Interventions for Myopia Control in Children: A Network Meta-analysis. Ophthalmology. 2016 Apr;123(4):697-708. doi: 10.1016/j.ophtha.2015.11.010. Epub 2016 Jan 27. |
| 27101751 | Background | Polling JR, Kok RG, Tideman JW, Meskat B, Klaver CC. Effectiveness study of atropine for progressive myopia in Europeans. Eye (Lond). 2016 Jul;30(7):998-1004. doi: 10.1038/eye.2016.78. Epub 2016 Apr 22. |
| 26271839 | Background | Chia A, Lu QS, Tan D. Five-Year Clinical Trial on Atropine for the Treatment of Myopia 2: Myopia Control with Atropine 0.01% Eyedrops. Ophthalmology. 2016 Feb;123(2):391-399. doi: 10.1016/j.ophtha.2015.07.004. Epub 2015 Aug 11. |
| 24076540 | Background | Cooper J, Eisenberg N, Schulman E, Wang FM. Maximum atropine dose without clinical signs or symptoms. Optom Vis Sci. 2013 Dec;90(12):1467-72. doi: 10.1097/OPX.0000000000000037. |
| 38621178 | Derived | Tran HDM, Ha TTX, Tran YH, Coroneo M, Tran TD, Truong TU, Sankaridurg P. Impact of Various Concentrations of Low-Dose Atropine on Pupillary Diameter and Accommodative Amplitude in Children with Myopia. J Ocul Pharmacol Ther. 2024 May;40(4):232-239. doi: 10.1089/jop.2023.0173. Epub 2024 Apr 15. |