A Phase 3 interventional study of brilliant blue G in Macular Hole and Epiretinal Membrane, sponsored by Asociación para Evitar la Ceguera en México. Terminated at 1 site in Mexico. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-05-30.
Sponsored by Asociación para Evitar la Ceguera en México · Phase 3, Interventional, and Treatment
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's enrollment of 22 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: brilliant blue G
Double staining with brilliant blue G 0.025% for macular surgery
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
Time frame: 6 months
Amplitude of pattern reversal electroretinogram
Amplitude of pattern reversal electroretinogram (in microvolts)
Time frame: 6 months
Amplitude of b-wave of multifocal electroretinogram
Measurement of the amplitude of the b-wave of multifocal electroretinogram
Time frame: 6 months
Visual acuity
Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart
Time frame: 6 months
Complications
Presence of any ocular complication
Time frame: 6 months
The record gives a start of Jan 2013, a primary completion of Feb 2014 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.
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This study is terminated, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Asociación para Evitar la Ceguera en México