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

• Sponsor: Asociación para Evitar la Ceguera en México (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01820520
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Hole; Epiretinal Membrane	Drug: brilliant blue G	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Safety and Efficacy of Double Staining With Brilliant Blue G for Macular Surgery
• Study Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Sep 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

2. Amplitude of pattern reversal electroretinogram [6 months]

   Amplitude of pattern reversal electroretinogram (in microvolts)

3. Amplitude of b-wave of multifocal electroretinogram [6 months]

   Measurement of the amplitude of the b-wave of multifocal electroretinogram

Secondary Outcome Measures

1. Visual acuity [6 months]

   Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart

2. Complications [6 months]

   Presence of any ocular complication

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asociación para Evitar la Ceguera en México	Mexico City	DF	Mexico	04030

Sponsors and Collaborators

• Asociación para Evitar la Ceguera en México

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hugo Sepúlveda-Vázquez, Retina Fellow, Asociación para Evitar la Ceguera en México
• ClinicalTrials.gov Identifier: NCT01820520
• Other Study ID Numbers: RE11-09
• First Posted: Mar 28, 2013
• Last Update Posted: Mar 28, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Retinal Perforations; Epiretinal Membrane

Study Results

No Results Posted as of Mar 28, 2013