2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides

Phase 4

Completed

• Conditions: Diabetes Mellitus

• Registration Number: NCT00501878
• Lead Sponsor: Khon Kaen University

Brief Summary

To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.

Detailed Description

One hundred patients with diabetes from Srinagarind Hospital Eye Clinic were enrolled and randomized into two groups by block randomization. In group I (50 patients), 1% tropicamide combined with 2.5% phenylephrine were administered to dilate pupil whereas 1% tropicamide combined with 10% phenylephrine were used in Group II (50 patients). Pupil diameter, blood pressure and heart rate were measured before and after eye drop instillations.

Study Timeline

• Study Start: 2007-05
• Study Completion: 2007-07
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-16
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-07
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• diabetic patients

Exclusion Criteria

• history of intraocular surgery or laser treatment,
• any ocular diseases that might affect pupil size such as glaucoma,uveitis,Horner's syndrome, Adies' pupil,
• history of allergy to any drug used, and
• hypertension

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pupil diameters were measured.	before and after phenylephrine eye drop instillations

Secondary Outcome Measures

Name	Time	Method
blood pressure and heart rate were measured	before and after phenylephrine eye drop instillations

Trial Locations

Locations (1)

Srinagarind Hospital Eye Clinic; 🇹🇭 Khon Kaen, Thailand