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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260320007

Enrollment

Registered

2026-03-20

Start date

2024-11-04

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pupillary dilation for retinal examination in diabetic patients Pupillary dilation in ophthalmic patients Pupil Dilatation Topical administration Anesthetics Diabetic retinopathy

Interventions

One drop of 0.8% tropicamide + 5% phenylephrine combination,One drop of 0.5% tetracaine and one drop of 0.8% tropicamide + 5% phenylephrine combination,Three drops of 0.8% tropicamide + 5% phenylephri

Experimental Drug,Experimental Drug,Experimental Drug,Experimental Drug

Group 1,Group 2,Group 3,Group 4

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Diabetic patients scheduled for diabetic retinopathy screening at the outpatient department

Exclusion criteria

Exclusion criteria: 1. Conditions affecting pupillary reaction 2. Known allergies to the study medications 3. Systolic blood pressure > 160 mmHg 4. Diastolic blood pressure >100 mmHg 5. Pulse rate > 100/min

Design outcomes

Primary

Measure	Time frame
Pupillary diameter 0, 10, 20, 30 minutes millimeters	—

Secondary

Measure	Time frame
Systolic blood pressure 0, 10, 20, 30 minutes mmHg,Diastolic blood pressure 0, 10, 20, 30 minutes mmHg,Pulse rate 0, 10, 20, 30 minutes bpm,Ocular discomfort 30 minutes Pain score	—

Countries

Thailand

Contacts

Public ContactNattawat Asawaworarit

Faculty of Medicine, Burapha University

nattawata@go.buu.ac.th038386554

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026