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

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.

Study Overview

• Status: Unknown
• Conditions: Epiretinal Membrane; Macular Hole
• Intervention / Treatment: Drug: brilliant blue G

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Hugo Sepúlveda-Vázquez, MD; Phone Number: 1172 +52(55)10841400; Email: hugo_dr14@hotmail.com
• Study Contact Backup: Name: Gerardo Garcia-Aguirre, MD; Phone Number: 1172 +52(55)10841400; Email: jerry_gar@hotmail.com

Study Locations

• Mexico
  • DF
    • Mexico City, DF, Mexico, 04030
      • Recruiting
      • Asociación Para Evitar la Ceguera en México
      • Contact: Antonieta Burgoa; Phone Number: 1172 +52(55)10841400; Email: retinamex@yahoo.com
      • Principal Investigator: Hugo Sepúlveda-Vázquez, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double staining with brilliant blue G during vitrectomy	Drug: brilliant blue G; Double staining with brilliant blue G 0.025% for macular surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography	Average thickness of ganglion cell layer - inner plexiform layer measured by spectral domain optical coherence tomography	6 months
Amplitude of pattern reversal electroretinogram	Amplitude of pattern reversal electroretinogram (in microvolts)	6 months
Amplitude of b-wave of multifocal electroretinogram	Measurement of the amplitude of the b-wave of multifocal electroretinogram	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity	Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart	6 months
Complications	Presence of any ocular complication	6 months

Collaborators and Investigators

• Sponsor: Asociación para Evitar la Ceguera en México

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Anticipated): September 1, 2013

Study Registration Dates

• First Submitted: March 26, 2013
• First Submitted That Met QC Criteria: March 27, 2013
• First Posted (Estimate): March 28, 2013

Study Record Updates

• Last Update Posted (Estimate): March 28, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations; Epiretinal Membrane
• Other Study ID Numbers: RE11-09