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

NCT07495670 | Completed

• 1 other identifier: IRB1-052/2567
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes (DM); Retinopathy, Diabetic; Pupil Dilation

Keywords

Pupil; Dilatation; Administration, Topical; Anesthetics; Retinopathy, Diabetic

Outcome Measures

Primary Outcomes (1)

• Pupillary size

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

  30 minutes

Secondary Outcomes (4)

• Systolic blood pressure

  30 minutes

• Diastolic blood pressure

  30 minutes

• Pulse rate

  30 minutes

• Ocular discomfort

  When all measurements concluded (at minute 30)

Study Arms (4)

1 drop

EXPERIMENTAL

1 drop of a 0.8% tropicamide - 5% phenylephrine combination

Drug: 1 drop of a 0.8% tropicamide + 5% phenylephrine combination

2 drops

EXPERIMENTAL

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

EXPERIMENTAL

3 drops of a 0.8% tropicamide - 5% phenylephrine combination

Drug: 3 drops of a 0.8% tropicamide + 5% phenylephrine combination

4 drops

EXPERIMENTAL

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

Interventions

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

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

2 drops

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

3 drops

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

4 drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Burapha University: lead

Study Sites (1)

Burapha University

Chon Buri, 20131, Thailand

Location

Related Publications (23)

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  PMID: 655237 BACKGROUND

• Motta MM, Coblentz J, Fernandes BF, Burnier MN Jr. Mydriatic and cardiovascular effects of phenylephrine 2.5% versus phenylephrine 10%, both associated with tropicamide 1%. Ophthalmic Res. 2009;42(2):87-9. doi: 10.1159/000220601. Epub 2009 May 27.

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• Pollack SL, Hunt JS, Polse KA. Dose-response effects of tropicamide HCl. Am J Optom Physiol Opt. 1981 May;58(5):361-6. doi: 10.1097/00006324-198105000-00003.

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MeSH Terms

Conditions

Diabetes Mellitus; Diabetic Retinopathy; Mydriasis; Dilatation, Pathologic

Interventions

Tropicamide; Tetracaine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Pupil Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Nattawat Asawaworarit, M.D.

  Burapha University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: March 27, 2026
• Study Start: November 4, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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

Locations

TH (1)