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

• Sponsor: Khon Kaen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00501878
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 49.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: 2.5% or 10% phenylephrine	Phase 4

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Diagnostic
• Official Title: 2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
• Study Start Date: May 1, 2007
• Actual Study Completion Date: Jul 1, 2007

Outcome Measures

Primary Outcome Measures

1. Pupil diameters were measured. [before and after phenylephrine eye drop instillations]

Secondary Outcome Measures

1. blood pressure and heart rate were measured [before and after phenylephrine eye drop instillations]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Srinagarind Hospital Eye Clinic	Khon Kaen		Thailand	40002

Sponsors and Collaborators

• Khon Kaen University

Investigators

• Principal Investigator: Yosanan Yospaiboon, M.D., Khon Kaen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
• ClinicalTrials.gov Identifier: NCT00501878
• Other Study ID Numbers: I50138; HE490619
• First Posted: Jul 16, 2007
• Last Update Posted: Mar 9, 2012
• Last Verified: Mar 1, 2012

• Keywords provided by Yosanan Yospaiboon, Professor, Khon Kaen University: phenylephrine; mydriasis; diabetes mellitus
• Additional relevant MeSH terms: Mydriasis; Diabetes Mellitus; Phenylephrine; Oxymetazoline

Study Results

No Results Posted as of Mar 9, 2012