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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University
ClinicalTrials.gov Identifier:
NCT00501878
First received: July 13, 2007
Last updated: March 7, 2012
Last verified: March 2012
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: 2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides

Resource links provided by NLM:

MedlinePlus related topics: Diabetes
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • blood pressure and heart rate were measured [ Time Frame: before and after phenylephrine eye drop instillations ] [ Designated as safety issue: Yes ]

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

Publications:

Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University
ClinicalTrials.gov Identifier: NCT00501878     History of Changes
Other Study ID Numbers: I50138, HE490619
Study First Received: July 13, 2007
Last Updated: March 7, 2012
Health Authority: Thailand: Khon Kaen University Ethics Committee for Human Research

Keywords provided by Khon Kaen University:
phenylephrine
mydriasis
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Mydriasis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pupil Disorders
Eye Diseases
Phenylephrine
Oxymetazoline
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Protective Agents

ClinicalTrials.gov processed this record on June 18, 2013