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

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ClinicalTrials.gov Identifier: NCT00501878
Recruitment Status : Completed
First Posted : July 16, 2007
Last Update Posted : March 9, 2012
Sponsor:
Information provided by (Responsible Party):

July 13, 2007
July 16, 2007
March 9, 2012
May 2007
Not Provided
Pupil diameters were measured. [ Time Frame: before and after phenylephrine eye drop instillations ]
Same as current
Complete list of historical versions of study NCT00501878 on ClinicalTrials.gov Archive Site
blood pressure and heart rate were measured [ Time Frame: before and after phenylephrine eye drop instillations ]
Same as current
Not Provided
Not Provided
 
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Diabetes Mellitus
Drug: 2.5% or 10% phenylephrine
Not Provided
Suwan-Apichon O, Ratanapakorn T, Panjaphongse R, Sinawat S, Sanguansak T, Yospaiboon Y. 2.5% and 10% phenylephrine for mydriasis in diabetic patients with darkly pigmented irides. J Med Assoc Thai. 2010 Apr;93(4):467-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2007
Not Provided

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
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT00501878
I50138
HE490619 ( Other Identifier: Khon Kaen University Ethics Committee )
Yes
Not Provided
Not Provided
Yosanan Yospaiboon, Khon Kaen University
Khon Kaen University
Not Provided
Principal Investigator: Yosanan Yospaiboon, M.D. Khon Kaen University
Khon Kaen University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP