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NCT Number: NCT07495670

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

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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Key information

Conditions

Diabetes (DM) Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Dilatation, Pathologic Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Metabolic Diseases Mydriasis Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pupil Dilation Pupil Disorders Retinal Diseases Retinopathy, Diabetic Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Burapha University

Chon Buri, 20131, Thailand

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Pupillary size

    Time frame: 30 minutes

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

Secondary outcomes

  1. Systolic blood pressure

    Time frame: 30 minutes

    Measurement of systolic blood pressure (at baseline, then every 10 minutes)

  2. Diastolic blood pressure

    Time frame: 30 minutes

    Measurement of diastolic blood pressure (at baseline, then every 10 minutes)

  3. Pulse rate

    Time frame: 30 minutes

    Measurement of pulse rate (at baseline, then every 10 minutes)

  4. Ocular discomfort

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Burapha University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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