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

A

Asociación para Evitar la Ceguera en México

Status and phase

Terminated
Phase 3

Conditions

Macular Hole
Epiretinal Membrane

Treatments

Drug: brilliant blue G

Study type

Interventional

Funder types

Other

Identifiers

NCT01820520
RE11-09

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

22 participants in 1 patient group

Double staining with brilliant blue G during vitrectomy
Experimental group
Treatment:
Drug: brilliant blue G

Trial contacts and locations

1

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Central trial contact

Hugo Sepúlveda-Vázquez, MD; Gerardo Garcia-Aguirre, MD

Data sourced from clinicaltrials.gov

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