Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
- Registration Number
- NCT01820520
- Lead Sponsor
- Asociación para Evitar la Ceguera en México
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 22
- Patient age 18 years of older
- Signing of informed consent
- Macular pathology requiring vitrectomy (epiretinal membrane, macular hole, vitreomacular traction syndrome)
- Diagnosis of glaucoma
- Known allergy to brilliant blue G
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Double staining with brilliant blue G during vitrectomy brilliant blue G -
- Primary Outcome Measures
Name Time Method Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography 6 months Average thickness of ganglion cell layer - inner plexiform layer measured by spectral domain optical coherence tomography
Amplitude of b-wave of multifocal electroretinogram 6 months Measurement of the amplitude of the b-wave of multifocal electroretinogram
Amplitude of pattern reversal electroretinogram 6 months Amplitude of pattern reversal electroretinogram (in microvolts)
- Secondary Outcome Measures
Name Time Method Visual acuity 6 months Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart
Complications 6 months Presence of any ocular complication
Trial Locations
- Locations (1)
Asociación para Evitar la Ceguera en México
🇲🇽Mexico City, DF, Mexico