Macular Edema
Conditions
Interventions
The sample will consist of 12 diabetic volunteers with DME (diabetic macular edema). During the screening visit, a complete ophthalmologic evaluation, including corrected visual acuity (BCVA), slit-la
Sponsors
Universidade Federal de Pernambuco
Universidade Federal de Pernambuco
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: age 18 or older; diagnosis of diabetes mellitus; presence of clinically significant bilateral diabetic macular edema; best corrected visual acuity between 20/400 and 20/40; central macular thickness >= 300 µm, measured by spectral domain optical coherence tomography.
Exclusion criteria
Exclusion criteria: Any treatment for diabetic macular edema in the past 4 months; Panretinal photocoagulation within the past 4 months; Any eye surgery performed within the past 4 months; History of pars plano vitrectomy; History of open-angle glaucoma or corticosteroid-induced elevated intraocular pressure requiring ocular antiglaucoma or antihypertensive treatment; Intraocular pressure >= 21 mmHg; History of allergy to any product used in the procedure; Presence of tractional retinal detachment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in macular thickness 3 days after intravitreal dexamethasone, verified by means of optical coherence tomography, based on the verification of a variation of at least 10% in pre- and post-intervention measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to find a reduction in macular thickness 1 day after intravitreal dexamethasone, verified using optical coherence tomography, based on the verification of a variation of at least 5% in pre- and post-intervention measurements;It is expected that no change in macular thickness will be found 7 and 30 days after intravitreal dexamethasone, verified by means of optical coherence tomography, based on the verification of a variation of at least 5% in pre- and post-intervention measurements;It is expected that no change in visual acuity will be found 1, 3, 7 and 30 days after intravitreal dexamethasone, verified by measuring the corrected visual acuity, based on the verification of a variation of at least 10% in the pre- and post-treatment measurements. intervention;It is expected not to find changes in intraocular pressure 1, 3, 7 and 30 days after intravitreal dexamethasone, verified by measuring applanation tonometry, based on the verification of a variation of at least 10% in pre- and post-treatment measurements. intervention | — |
Countries
Brazil
Contacts
Public ContactRodrigo Lira
Universidade Federal de Pernambuco
Outcome results
None listed