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

Primary Purpose

Macular Hole, Epiretinal Membrane

Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
brilliant blue G
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Hole

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asociación para Evitar la Ceguera en MéxicoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Double staining with brilliant blue G during vitrectomy

Arm Description

Outcomes

Primary Outcome Measures

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
Amplitude of pattern reversal electroretinogram
Amplitude of pattern reversal electroretinogram (in microvolts)
Amplitude of b-wave of multifocal electroretinogram
Measurement of the amplitude of the b-wave of multifocal electroretinogram

Secondary Outcome Measures

Visual acuity
Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart
Complications
Presence of any ocular complication

Full Information

First Posted
March 26, 2013
Last Updated
March 27, 2013
Sponsor
Asociación para Evitar la Ceguera en México
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1. Study Identification

Unique Protocol Identification Number
NCT01820520
Brief Title
Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
Official Title
Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
September 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asociación para Evitar la Ceguera en México

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Hole, Epiretinal Membrane

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Double staining with brilliant blue G during vitrectomy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
brilliant blue G
Intervention Description
Double staining with brilliant blue G 0.025% for macular surgery
Primary Outcome Measure Information:
Title
Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography
Description
Average thickness of ganglion cell layer - inner plexiform layer measured by spectral domain optical coherence tomography
Time Frame
6 months
Title
Amplitude of pattern reversal electroretinogram
Description
Amplitude of pattern reversal electroretinogram (in microvolts)
Time Frame
6 months
Title
Amplitude of b-wave of multifocal electroretinogram
Description
Measurement of the amplitude of the b-wave of multifocal electroretinogram
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart
Time Frame
6 months
Title
Complications
Description
Presence of any ocular complication
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hugo Sepúlveda-Vázquez, MD
Phone
+52(55)10841400
Ext
1172
Email
hugo_dr14@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gerardo Garcia-Aguirre, MD
Phone
+52(55)10841400
Ext
1172
Email
jerry_gar@hotmail.com
Facility Information:
Facility Name
Asociación para Evitar la Ceguera en México
City
Mexico City
State/Province
DF
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonieta Burgoa
Phone
+52(55)10841400
Ext
1172
Email
retinamex@yahoo.com
First Name & Middle Initial & Last Name & Degree
Hugo Sepúlveda-Vázquez, MD

12. IPD Sharing Statement

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

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