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

Khon Kaen University

Status and phase

Completed

Phase 3

Conditions

Eye Diseases

Treatments

Drug: 1% tropicamide and 10% phenylephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT00120432

HE461104

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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