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The purpose of this study is to compare the efficacy on pupillary dilation between the single dose versus the three doses of 1% tropicamide with 10% phenylephrine for complete ocular examination.
To the best of the authors' knowledge, there have been no clinical trials using an appropriate regimen for pupillary dilation up until now. Therefore, the authors were interested to find out the most appropriate regimen for complete ocular examination, based on the finding that a pupil diameter of 6 mm or greater is adequate for indirect ophthalmoscopy. The authors hypothesize that a single dose of 1% tropicamide and 10% phenylephrine is adequate to complete the job and are conducting this prospective randomized clinical controlled trial to prove the hypothesis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | single dose vs three doses of 1%tropicamide and 10%phenylephrine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1% tropicamide and 10% phenylephrine | Drug | single dose vs three doses of 1%tropicamide and 10%phenylephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| horizontal pupil diameter | 30 min |
| Measure | Description | Time Frame |
|---|---|---|
| systolic blood pressure | 30 min | |
| diastolic blood pressure | 30 min | |
| heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yosanan Yospaiboon, M.D. | Khon Kaen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Srinagarind Hospital | Khon Kaen | Changwat Khon Kaen | 40002 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17205877 | Result | Ratanapakorn T, Yospaiboon Y, Chaisrisawadsuk N. Single dose of 1% tropicamide and 10% phenylephrine for pupil dilation. J Med Assoc Thai. 2006 Nov;89(11):1934-9. |
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| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D015878 | Mydriasis |
| ID | Term |
|---|---|
| D011681 | Pupil Disorders |
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| ID | Term |
|---|---|
| D014331 | Tropicamide |
| D010656 | Phenylephrine |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004983 | Ethanolamines |
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| 30 min |
| adverse drug reaction | 30 min |
| D000605 |
| Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |