The effect of local anaesthetising eye drops for pupil dilatation in patients examined for retinal complications secondary to diabetes mellitus

The effect of topical anaesthesia on pharmacological mydriasis in patients screened for diabetic retinopathy - OXYDILAT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003252-37-DK

Enrollment

Unknown

Registered

2012-10-08

Start date

2012-10-08

Completion date

Unknown

Last updated

2016-08-08

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

Conditions

Diabetic retinopathy MedDRA version: 15.0 Level: LLT Classification code 10013007 Term: Dilatation pupillary System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Oxybuprocain Product Name: Oxybuprocain Pharmaceutical Form: Eye drops INN or Proposed INN: OXYBUPROCAINE CAS Number: 99-43-4 Concentration unit: µg/ml microgram(s)/millilitre Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients screened for diabetic retinopathy Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: Persons below the age of 18 years Persons with previous eye diseases affecting pupil mobility Pregnant and lactating women

Design outcomes

Primary

Measure	Time frame
Main Objective: Improved dilatation of the pupil;Secondary Objective: Not applicable;Primary end point(s): Significant difference in pupil diameter;Timepoint(s) of evaluation of this end point: At inclusion	—

Secondary

Measure	Time frame
Secondary end point(s): Patient discomfort during topical application of eye drops;Timepoint(s) of evaluation of this end point: At inclusion	—

Countries

Denmark

Contacts

Public ContactToke Bek

Aarhus University Hospital, Department of Ophthalmology

toke.bek@mail.tele.dk+4578463222

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026