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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501878
• Other study ID #: I50138
• Secondary ID: HE490619
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2007
• Last updated: March 7, 2012
• Start date: May 2007
• Est. completion date: July 2007

Study information

• Verified date: March 2012
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Khon Kaen University Ethics Committee for Human Research
• Study type: Interventional

Clinical Trial Summary

To compare the clinical efficacy and systemic side effects between 2.5% and 10% phenylephrine for mydriasis in diabetic patient with darkly pigmented irides.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus
• Mydriasis

Intervention

Drug:
• 2.5% or 10% phenylephrine

Locations

Country	Name	City	State
Thailand	Srinagarind Hospital Eye Clinic	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil diameters were measured.		before and after phenylephrine eye drop instillations	No
Secondary	blood pressure and heart rate were measured		before and after phenylephrine eye drop instillations	Yes