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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501878
First Posted: July 16, 2007
Last Update Posted: March 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yosanan Yospaiboon, Khon Kaen University
  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
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

Resource links provided by NLM:


Further study details as provided by Yosanan Yospaiboon, 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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: Khon Kaen University Ethics Committee )
First Submitted: July 13, 2007
First Posted: July 16, 2007
Last Update Posted: March 9, 2012
Last Verified: March 2012

Keywords provided by Yosanan Yospaiboon, 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
Cardiotonic Agents
Mydriatics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Sympathomimetics
Vasoconstrictor Agents
Nasal Decongestants
Respiratory System Agents
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents