Prophylactic effect of brimonidine on bleeding subconjunctival in 23G vitrectomy

Prophylactic effect of brimonidine on bleeding subconjunctival in 23G vitrectomy - EPROBRI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002895-15-ES

Enrollment

Unknown

Registered

2012-09-07

Start date

2012-12-19

Completion date

Unknown

Last updated

2017-05-22

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

Conditions

Subconjunctival haemorrhages after surgery of vitrectomía with 23G MedDRA version: 15.0 Level: LLT Classification code 10042341 Term: Subconjunctival haemorrhage System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: ALFADINA 2mg/ml, colirio en solución Pharmaceutical Form: Eye drops, solution INN or Proposed INN: BRIMONIDINE TARTRATE CAS Number: 79570-19-7 Concentration unit: mg/ml milligram(s)/millil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Women and men over 18 years 2. Patients who are going to be operated on 23G vitrectomy 3. To sign the informed consent. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. Other associated surgeries that incluye conjunctival incision 2. Known allergy to study drug 3. Subconjunctival haemorrhage in the eye of the study before the start of premedication, from any source (trauma, previous surgery)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if it can be prevented and in that percentage the appearance of subconjunctival haemorrhages after surgery of vitrectomía with 23G, by means of the use of brimonidina in collyrium in the preoperative medication.;Secondary Objective: To determine if there are individual preconditions that alter the response;Primary end point(s): Number of quadrants affected by subconjunctival haemorrhage at each follow-up visit.;Timepoint(s) of evaluation of this end point: 1 week	—

Measure

Time frame

Main Objective: To determine if it can be prevented and in that percentage the appearance of subconjunctival haemorrhages after surgery of vitrectomía with 23G, by means of the use of brimonidina in collyrium in the preoperative medication.;Secondary Objective: To determine if there are individual preconditions that alter the response;Primary end point(s): Number of quadrants affected by subconjunctival haemorrhage at each follow-up visit.;Timepoint(s) of evaluation of this end point: 1 week

—

Secondary

Measure	Time frame
Secondary end point(s): If the patient is hypertensive or diabetic or is taking antiplatelet agents or anticoagulants.;Timepoint(s) of evaluation of this end point: 1 week	—

Countries

Spain

Contacts

Public ContactDepartamento Administración/ Invest

Fundación Oftalmológica del Mediterráneo

fom@fom.es+003496232 81 00

Outcome results

None listed

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