Vitreorretinal surgery with and without oral anticoagulants: results and complications.

Phase 1

• Conditions: Patients undergoing vitreoretinal surgery under treatment with oral anticoagulants; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2018-000753-45-ES
• Lead Sponsor: AVARRBIOMED-FUNDACION MIGUEL SERVET

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-20
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Adults (over 18 years) of both sexes.
2. Clinical indication for vitrectomy alone or associated with facoemulsification or scleral buckling.
3. Under treatment with any of the following oral anticoagulants: acenocumarol, dabigatran, rivaroxaban, apixaban or edoxaban.
4. Able to give informed consent for vitreoretinal surgery and to participate in the trial.
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 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

1. Patients unable to be operated under retrobulbar anesthesia.
2. Patients on antiplatelet therapy except if the antiaggregation is with acetylsalicylic acid.
3. Patients who have recently started oral anticoagulation (less than 1 month before screening).
4. Any medical, psychological, psychiatric, geographic or social situation that could interfere with the participation of the patient in the trial or with the follow-up and adherence with the protocol and the evaluation of the results of the present trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified