An interventional study of 1 drop of a 0.8% tropicamide + 5% phenylephrine combination and 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination in Diabetes (DM), Retinopathy, Diabetic and Pupil Dilation, sponsored by Burapha University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Burapha University · Not applicable, Interventional, and Diagnostic
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.
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.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
This study's enrollment of 84 is close to the median of 80 across 481 interventional studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Burapha University is the lead sponsor of 15 studies on the registry; 4 are open to participants now.
Compared within Diabetic Retinopathy, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Diabetes Mellitus. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Exclusion Criteria:
1 drop of a 0.8% tropicamide - 5% phenylephrine combination
Drug: 1 drop of a 0.8% tropicamide + 5% phenylephrine combination
1 drop of tetracaine and 1 drop of a 0.8% tropicamide - 5% phenylephrine combination
Drug: 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination
3 drops of a 0.8% tropicamide - 5% phenylephrine combination
Drug: 3 drops of a 0.8% tropicamide + 5% phenylephrine combination
1 drop of tetracaine and 3 drops of a 0.8% tropicamide - 5% phenylephrine combination
Drug: 1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination
1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
1 drop of 0.5% tetracaine (anesthetics) and 1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
1 drop of 0.5% tetracaine (anesthetics) and 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
Pupillary size
Measurement of pupillary size in millimeters (at baseline, then every 10 minutes)
Time frame: 30 minutes
Systolic blood pressure
Measurement of systolic blood pressure (at baseline, then every 10 minutes)
Time frame: 30 minutes
Diastolic blood pressure
Measurement of diastolic blood pressure (at baseline, then every 10 minutes)
Time frame: 30 minutes
Pulse rate
Measurement of pulse rate (at baseline, then every 10 minutes)
Time frame: 30 minutes
Ocular discomfort
Patients report of ocular discomfort during topical administration and the measurement of pupillary size in pain score (0-10)
Time frame: When all measurements concluded (at minute 30)
Plan to share: Yes — IPD used in the results publication
Supporting information: Study protocol
Time frame: IPD and supporting information will be available one year after publicaiton and for two years period.
Access criteria: Direct contact to the corresponding author
Ran from Nov 2024 to primary completion in Jan 2025, 2 months.
Of 111 non-industry interventional studies with no phase under Diabetic Retinopathy, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 60. This study's 2 months is below that.
Counting every sponsor, half of 126 studies reached it within 29 months; a quarter within 11 and three quarters within 60.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Burapha University