TerminatedPhase 3

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

Stopped: Undefined

Mexico22 participantsStarted 2013-01

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Thickness of ganglion cell layer - inner plexiform layer measured by optical coherence tomography

Timeframe: 6 months

Amplitude of pattern reversal electroretinogram

Timeframe: 6 months

Amplitude of b-wave of multifocal electroretinogram

Timeframe: 6 months

Trial details

NCT IDNCT01820520

SponsorAsociación para Evitar la Ceguera en México

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-02

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