2.5% and 10% Phenylephrine for Mydriasis in Diabetic Pati... | NCT00501878

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

NCT00501878

Sponsor

Khon Kaen University

Status

Completed

Last Update Posted

Mar 9, 2012Estimated

Enrollment

100Actual

Phase

Phase 4

Conditions

Diabetes Mellitus

Interventions

2.5% or 10% phenylephrine

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HE490619	Other Identifier	Khon Kaen University Ethics Committee

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Jul 13, 2007

First Submission Date that Met QC Criteria

Jul 13, 2007

First Posted Date

Jul 16, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2012

Last Update Posted Date

Mar 9, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Name	Type	Description	Arm Group Labels	Other Names
2.5% or 10% phenylephrine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pupil diameters were measured.		before and after phenylephrine eye drop instillations

Secondary Outcomes

Measure	Description	Time Frame
blood pressure and heart rate were measured		before and after phenylephrine eye drop instillations

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yosanan Yospaiboon, M.D.	Khon Kaen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Srinagarind Hospital Eye Clinic		Khon Kaen	Changwat Khon Kaen	40002	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20462091	Result	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.

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

ID	Term
D003920	Diabetes Mellitus
D015878	Mydriasis