Back to results2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
Primary Purpose
Diabetes Mellitus
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
2.5% or 10% phenylephrine
Sponsored by
About this trial
This is an interventional diagnostic trial for Diabetes Mellitus focused on measuring phenylephrine, mydriasis, diabetes mellitus
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
Sites / Locations
- Srinagarind Hospital Eye Clinic
Outcomes
Primary Outcome Measures
Pupil diameters were measured.
Secondary Outcome Measures
blood pressure and heart rate were measured
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00501878
Brief Title
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
Official Title
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus
Keywords
phenylephrine, mydriasis, diabetes mellitus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
2.5% or 10% phenylephrine
Primary Outcome Measure Information:
Title
Pupil diameters were measured.
Time Frame
before and after phenylephrine eye drop instillations
Secondary Outcome Measure Information:
Title
blood pressure and heart rate were measured
Time Frame
before and after phenylephrine eye drop instillations
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yosanan Yospaiboon, M.D.
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind Hospital Eye Clinic
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
20462091
Citation
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.
Results Reference
result
Learn more about this trial
2.5% and 10% Phenylephrine for Mydriasis in Diabetic Patients With Darkly Pigmented Irides
We'll reach out to this number within 24 hrs