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

Burapha University84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

Conditions

Diabetes (DM)Retinopathy, Diabetic Pupil Dilation

Interventions

1 drop of a 0.8% tropicamide + 5% phenylephrine combinationDRUG

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 combinationDRUG

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 combinationDRUG

3 drops of a 0.8% tropicamide (muscarinic antagonist) + 5% phenylephrine (α1-adrenergic agonist) combination

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Burapha University

Chon Buri, Thailand

Outcomes

Primary Outcomes

Pupillary size

Measurement of pupillary size in millimeters (at baseline, then every 10 minutes)

Time frame: 30 minutes

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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