Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery

Asociación para Evitar la Ceguera en México

Status and phase: Terminated; Phase 3

Conditions: Macular Hole; Epiretinal Membrane

Treatments: Drug: brilliant blue G

Study type: Interventional

Funder types: Other

Identifiers

NCT01820520

RE11-09

Details and patient eligibility

About

Study designed to evaluate the safety and efficacy of double staining with brilliant blue G 0.025% as an adjuvant to macular surgery. Patients undergoing surgery for macular hole or epiretinal membrane will be included. Safety will be evaluated by optic coherence tomography, pattern reversal electroretinogram and multifocal electroretinogram.

Enrollment: 22 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient age 18 years of older
• Signing of informed consent
• Macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome)

Exclusion criteria

• Diagnosis of glaucoma
• Known allergy to brilliant blue G

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Double staining with brilliant blue G during vitrectomy

Experimental group

Treatment:

Drug: brilliant blue G