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

NCT ID: NCT00501878

Last Updated: 2012-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2007-07-31

Brief 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.

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Interventions

2.5% or 10% phenylephrine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Yosanan Yospaiboon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yosanan Yospaiboon, M.D.

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

Srinagarind Hospital Eye Clinic

Khon Kaen, Changwat Khon Kaen, Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 20462091 (View on PubMed)

Other Identifiers

HE490619

Identifier Type: OTHER

Identifier Source: secondary_id

I50138

Identifier Type: -

Identifier Source: org_study_id