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NCT01820520 Clinical Trial

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

Epiretinal Membrane Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01820520
Other study ID # RE11-09
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date January 2013
Est. completion date February 2014

Study information
Verified date May 2024
Source Asociación para Evitar la Ceguera en México
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 22
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• brilliant blue G
Double staining with brilliant blue G 0.025% for macular surgery

Locations
Country Name City State
Mexico Asociación para Evitar la Ceguera en México Mexico City DF

Sponsors (1)
Lead Sponsor Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary Amplitude of pattern reversal electroretinogram Amplitude of pattern reversal electroretinogram (in microvolts) 6 months
Primary Amplitude of b-wave of multifocal electroretinogram Measurement of the amplitude of the b-wave of multifocal electroretinogram 6 months
Secondary Visual acuity Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart 6 months
Secondary Complications Presence of any ocular complication 6 months
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