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NCT Number: NCT00501878

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Mydriasis Nutritional and Metabolic Diseases Pupil Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Srinagarind Hospital Eye Clinic

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2.5% or 10% phenylephrine

Drug

Primary outcomes

  1. Pupil diameters were measured.

    Time frame: before and after phenylephrine eye drop instillations

Secondary outcomes

  1. blood pressure and heart rate were measured

    Time frame: before and after phenylephrine eye drop instillations

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Important dates

Study start
2007
Study completion
2007
First posted
Jul 16, 2007
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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