2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides - Full Text View

Sponsored by:	Khon Kaen University
Information provided by:	Khon Kaen University
ClinicalTrials.gov Identifier:	NCT00501878

Purpose

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	Intervention	Phase
Diabetes Mellitus	Drug: 2.5% or 10% phenylephrine	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:

Pupil diameters were measured. [ Time Frame: before and after phenylephrine eye drop instillations ]

Secondary Outcome Measures:

blood pressure and heart rate were measured [ Time Frame: before and after phenylephrine eye drop instillations ]

Enrollment:	100
Study Start Date:	May 2007
Study Completion Date:	July 2007

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00501878

Locations

Thailand
Srinagarind Hospital Eye Clinic
Khon Kaen, Thailand, 40002

Sponsors and Collaborators

Khon Kaen University

Investigators

Principal Investigator:

Yosanan Yospaiboon, M.D.

Khon Kaen University

More Information

Study ID Numbers:	I50138, HE490619
Study First Received:	July 13, 2007
Last Updated:	July 18, 2007
ClinicalTrials.gov Identifier:	NCT00501878
Health Authority:	Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:

phenylephrine
mydriasis
diabetes mellitus

Study placed in the following topic categories:

Pseudoephedrine
Metabolic Diseases
Eye Diseases
Diabetes Mellitus
Endocrine System Diseases
Naphazoline
Oxymetazoline
Phenylephrine

Guaifenesin
Mydriasis
Ephedrine
Endocrinopathy
Phenylpropanolamine
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:

Respiratory System Agents
Pupil Disorders
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Sympathomimetics
Cardiotonic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Protective Agents
Adrenergic Agonists

Pharmacologic Actions
Nasal Decongestants
Anti-Obesity Agents
Mydriatics
Autonomic Agents
Expectorants
Therapeutic Uses
Vasoconstrictor Agents
Appetite Depressants
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009