Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2026-01-01 @ 5:41 PM
Study NCT ID:
NCT00120432
Status:
COMPLETED
Last Update Posted:
2012-03-09
First Post:
2005-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Sponsor:
Khon Kaen University
Organization:
Study Overview
Official Title:
Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: