NCT07495670

Comparison of 4 Methods of Eye Drops for Pupil Dilation in Diabetic Patients

Comparison of Mydriatic Effects Between 4 Regimens of a Tropicamide-Phenylephrine Combination in Diabetic Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Burapha University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Pupil dilation is required for many eye conditions. Diabetic patients may need more dilating eye drops to have pupil size large enough for eye exams. This study compares 4 methods of eye drops for pupil dilation in diabetic patients scheduled for retinopathy screening. Possible side effects of the eye drops are monitored during the study.

Detailed description

Diabetic patients participating in this study will be randomed to get 1 drop or 3 drops of dilating drug. And one eye of each patient will be randomed to get 1 drop of anesthetics, while the other eye does not. So there are 4 groups of eyes in the study. Group 1 receive 1 drop of dilating drug. Group 2 receive 1 drop of anesthetics + 1 drop of dilating drug. Group 3 receive 3 drops of dilating drug. And group 4 receive 1 drop of anesthetics + 3 drops of dilating drug. Pupil size will be measured before and after the drops.

Conditions

• Diabetes (DM)
• Retinopathy, Diabetic
• Pupil Dilation

Interventions

Type	Name	Description
DRUG	1 drop of a 0.8% tropicamide + 5% phenylephrine combination	1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
DRUG	1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination	1 drop of 0.5% tetracaine (anesthetics) and 1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
DRUG	3 drops of a 0.8% tropicamide + 5% phenylephrine combination	3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
DRUG	1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination	1 drop of 0.5% tetracaine (anesthetics) and 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: Thailand