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

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

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:

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.


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT00501878

Srinagarind Hospital Eye Clinic
Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
Principal Investigator: Yosanan Yospaiboon, M.D. Khon Kaen University
  More Information

Responsible Party: Yosanan Yospaiboon, Professor, Khon Kaen University 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:
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Eye Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Pupil Disorders
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-1 Receptor Agonists
Adrenergic alpha-Agonists
Autonomic Agents
Cardiotonic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Nasal Decongestants
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses
Vasoconstrictor Agents processed this record on November 20, 2014