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

NCT ID: NCT00120432

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-06-30

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.

Conditions

Eye Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

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

Group Type: ACTIVE_COMPARATOR

1% tropicamide and 10% phenylephrine

Intervention Type: DRUG

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

Interventions

1% tropicamide and 10% phenylephrine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Yosanan Yospaiboon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yosanan Yospaiboon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine, Khon Kaen University

Locations

Srinagarind Hospital

Khon Kaen, Changwat Khon Kaen, Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 17205877 (View on PubMed)

Other Identifiers

HE461104

Identifier Type: -

Identifier Source: org_study_id