Epiretinal Membrane, Macular Hole
Conditions
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.
Interventions
DRUGbrilliant blue G
Double staining with brilliant blue G 0.025% for macular surgery
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Amplitude of pattern reversal electroretinogram | 6 months | Amplitude of pattern reversal electroretinogram (in microvolts) |
| Amplitude of b-wave of multifocal electroretinogram | 6 months | Measurement of the amplitude of the b-wave of multifocal electroretinogram |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity | 6 months | Visual acuity measured with an Early Treatment Diabetic Retinopathy Study chart |
| Complications | 6 months | Presence of any ocular complication |
Countries
Mexico
Outcome results
None listed