Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial
Status:
Completed
Trial end date:
2018-10-05
Target enrollment:
Participant gender:
Summary
Purpose: To determine the impact of short-term 4mg/ml dexamethasone solution treatment in
diabetic macular edema (DME).
Design: Phase II, randomized, prospective, parallel, interventional study.
Participants: Pseudophakic patients with central-involved DME.
Methods: Twenty-seven patients with visual impairment caused by DME were randomized in a
1:1:1 ratio, in order to investigate treatment with 0.01 ml, 0.03 ml and 0.05 ml
intravitreous dexamethasone solutions, and followed-up over 28 days
Outcome Measures: The primary outcome was macular thickness at three days after intravitreous
dexamethasone. The secondary outcomes were macular thickness at 28 days after intravitreous
dexamethasone, best-corrected visual acuity (BCVA) and intraocular pressure (IOP) at three
and 28 days after intravitreous dexamethasone