Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

Eye Diseases Clinical Trial

Official title:

Single Dose of 1% Tropicamide and 10% Phenylephrine for Pupillary Dilation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00120432
• Other study ID #: HE461104
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2005
• Last updated: March 7, 2012
• Start date: December 2004
• Est. completion date: June 2005

Study information

• Verified date: March 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• aged between 20 and 80 years old

• dark iris

• require binocular indirect ophthalmoscopy for complete ocular examination

• signed written consent forms

Exclusion Criteria:

• history of ocular trauma

• history of intraocular surgery

• history of laser treatment

• previous eye drop instillation that may affect pupillary dilation

• ocular diseases that may affect pupil size such as Horner's syndrome, Adies' pupil, glaucoma and uveitis

• history of diabetes mellitus, severe hypertension and cardiovascular diseases

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Eye Diseases
• Mydriasis

Intervention

Drug:
• 1% tropicamide and 10% phenylephrine
single dose vs three doses of 1%tropicamide and 10%phenylephrine

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	horizontal pupil diameter		30 min	No
Secondary	systolic blood pressure		30 min	Yes
Secondary	diastolic blood pressure		30 min	Yes
Secondary	heart rate		30 min	Yes
Secondary	adverse drug reaction		30 min	Yes