NCT00501878

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4 diabetes-mellitus

Timeline
Completed

Started May 2007

Shorter than P25 for phase_4 diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 16, 2007

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

First QC Date

July 13, 2007

Last Update Submit

March 7, 2012

Conditions

Diabetes Mellitus

Keywords

phenylephrinemydriasisdiabetes mellitus

Outcome Measures

Primary Outcomes (1)

  • Pupil diameters were measured.

    before and after phenylephrine eye drop instillations

Secondary Outcomes (1)

  • blood pressure and heart rate were measured

    before and after phenylephrine eye drop instillations

Interventions

2.5% or 10% phenylephrineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diabetic patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Srinagarind Hospital Eye Clinic

Khon Kaen, Changwat Khon Kaen, 40002, Thailand

Location

Related 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.

    PMID: 20462091RESULT

MeSH Terms

Conditions

Diabetes MellitusMydriasis

Interventions

Phenylephrine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPupil DisordersEye Diseases

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAmines

Study Officials

  • Yosanan Yospaiboon, M.D.

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 13, 2007

First Posted

July 16, 2007

Study Start

May 1, 2007

Study Completion

July 1, 2007

Last Updated

March 9, 2012

Record last verified: 2012-03

Locations

TH(1)