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CompletedNCT00501878Updated Mar 9, 2012

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

A Phase 4 interventional study of 2.5% or 10% phenylephrine in Diabetes Mellitus, sponsored by Khon Kaen University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by Khon Kaen University · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetes Mellitus

Keywords

  • phenylephrine
  • mydriasis
  • diabetes mellitus
03

In context

Diabetes Mellitus

8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.

This study's enrollment of 100 is above the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Khon Kaen University is the lead sponsor of 161 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • diabetic patients

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Interventions

  • Drug2.5% or 10% phenylephrine
06

What researchers measure

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

07

Study locations

1 site
  • Srinagarind Hospital Eye Clinic
    Khon Kaen, 40002, Thailand
08

References and documents

Publications

  • 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. PubMed 20462091 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00501878
Responsible party
Yosanan Yospaiboon (Professor, Khon Kaen University) — Principal investigator
First posted
Jul 16, 2007
Start date
May 2007
Completion
Jul 2007
Last update
Mar 9, 2012

Study contacts

Yosanan Yospaiboon, M.D.
principal investigator · Khon Kaen University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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