Prophylactic effect of brimonidine on bleeding subconjunctival in 23G vitrectomy

Phase 1

Conditions: Subconjunctival haemorrhages after surgery of vitrectomía with 23G
MedDRA version: 15.0Level: LLTClassification code 10042341Term: Subconjunctival haemorrhageSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2012-002895-15-ES

Lead Sponsor: Fundación Oftalmológica del Mediterráneo

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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