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

NCT ID: NCT01820520

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Hole Epiretinal Membrane

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Double staining with brilliant blue G during vitrectomy

Group Type EXPERIMENTAL

brilliant blue G

Intervention Type DRUG

Double staining with brilliant blue G 0.025% for macular surgery

Interventions

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brilliant blue G

Double staining with brilliant blue G 0.025% for macular surgery

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Asociación para Evitar la Ceguera en México

Mexico City, Mexico City, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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RE11-09

Identifier Type: -

Identifier Source: org_study_id

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