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

NCT07495670 — Not applicable, Completed, 84 participants, Burapha University
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Comparison of Mydriatic Effects Between 4 Regimens of a Tropicamide-Phenylephrine Combination in Diabetic Patients

RegistryNCT07495670
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: double, diagnostic
Enrollment84 (Actual)
SponsorBurapha University (Other)
ConditionsDiabetes (DM), Retinopathy, Diabetic, Pupil Dilation
Interventions1 drop of a 0.8% tropicamide + 5% phenylephrine combination, 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, 1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination (Drug)
Datesstart 2024-11-04, primary completion 2025-01-31, completion 2025-01-31, first posted 2026-03-27, last updated 2026-03-27
Locations1 site in Thailand

Related Papers Related Patents Related Grants Related Experts
All trials for Diabetes (DM) All trials for Retinopathy, Diabetic All trials of 1 drop of a 0.8% tropicamide + 5% phenylephrine combination All trials of 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
1 dropExperimentalDrug: 1 drop of a 0.8% tropicamide + 5% phenylephrine combination1 drop of a 0.8% tropicamide - 5% phenylephrine combination
2 dropsExperimentalDrug: 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination1 drop of tetracaine and 1 drop of a 0.8% tropicamide - 5% phenylephrine combination
3 dropsExperimentalDrug: 3 drops of a 0.8% tropicamide + 5% phenylephrine combination3 drops of a 0.8% tropicamide - 5% phenylephrine combination
4 dropsExperimentalDrug: 1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination1 drop of tetracaine and 3 drops of a 0.8% tropicamide - 5% phenylephrine combination
  • 1 drop of a 0.8% tropicamide + 5% phenylephrine combination (Drug): 1 drop of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
  • 1 drop of 0.5% tetracaine and 1 drop of a 0.8% tropicamide + 5% phenylephrine combination (Drug): 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 + 5% phenylephrine combination (Drug): 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination
  • 1 drop of 0.5% tetracaine and 3 drops of a 0.8% tropicamide + 5% phenylephrine combination (Drug): 1 drop of 0.5% tetracaine (anesthetics) and 3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination

+Outcome measures

Primary outcomes

  • Pupillary size [30 minutes]: Measurement of pupillary size in millimeters (at baseline, then every 10 minutes)

Secondary outcomes

  • Systolic blood pressure [30 minutes]: Measurement of systolic blood pressure (at baseline, then every 10 minutes)
  • Diastolic blood pressure [30 minutes]: Measurement of diastolic blood pressure (at baseline, then every 10 minutes)
  • Pulse rate [30 minutes]: Measurement of pulse rate (at baseline, then every 10 minutes)
  • Ocular discomfort [When all measurements concluded (at minute 30)]: Patients report of ocular discomfort during topical administration and the measurement of pupillary size in pain score (0-10)

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Diabetic patients who were scheduled for diabetic retinopathy screening at OPD eye
* Age 18 years or older

Exclusion Criteria:

* Conditions potentially affecting pupillary reaction (e.g., history of uveitis, previous intraocular surgery, posterior synechiae)
* Known allergies to the study medications
* Systolic blood pressure > 160 mmHg
* Diastolic blood pressure > 100 mmHg
* Pulse rate > 100 beats/min

+Locations (1)

FacilityCityCountryStatus
Burapha UniversityChon BuriThailand

+Publications

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  • Leopold IH. The phenylephrine saga--a drug dilemma. Am J Ophthalmol. 1978 Apr;85(4):572-4. doi: 10.1016/s0002-9394(14)75261-4. No abstract available. PMID 655237
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+Investigators