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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00501878
Enrollment
100
Registered
2007-07-16
Start date
2007-05-31
Completion date
2007-07-31
Last updated
2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

phenylephrine, mydriasis, diabetes mellitus

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.

Interventions

DRUG2.5% or 10% phenylephrine

Sponsors

Khon Kaen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Pupil diameters were measured.before and after phenylephrine eye drop instillations

Secondary

MeasureTime frame
blood pressure and heart rate were measuredbefore and after phenylephrine eye drop instillations

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026