RESUMO
PURPOSE: To determine the effect of short-term 4 mg/mL dexamethasone solution treatment in diabetic macular edema (DME). PATIENTS AND METHODS: Twenty-seven pseudophakic diabetic patients with visual impairment caused by DME were randomized to receive 0.01 mL (40 µg), 0.03 mL (120 µg) or 0.05 mL (200 µg) intravitreal dexamethasone solution. Eyes were evaluated in terms of macular thickness, best-corrected visual acuity (BCVA) and intraocular pressure (IOP) at 3, 7 and 28 days after injection (D). RESULTS: There was a significant reduction in macular thickness between D0 and D3 for all groups (0.01 mL - P=0.008, 0.03 mL - P=0.038, and 0.05 mL - P=0.008). Between D0 and D7, a significant reduction in macular thickness was observed in 0.01 mL and 0.05 mL groups (0.01 mL - P=0.013 and 0.05 mL - P=0.021). Between D0 and D28, no significant reduction of macular thickness was observed for any group. Between D0 and D3, a significant improvement in BCVA in the 0.03 mL group (P=0.028) was observed. Between D0 and D7, a significant improvement in BCVA was observed in 0.01 mL and 0.03 mL groups (0.01 mL - P=0.018 and 0.03 mL - P=0.027). Between D0 and D28, a significant improvement in BCVA was observed for the 0.01 mL group (P=0.017). No significant differences in IOP measurements were observed for any group. Safety analysis revealed no serious ocular or systemic events. CONCLUSION AND RELEVANCE: Intravitreal dexamethasone solution is effective in reducing macular thickness secondary to DME in the short-term. Improvement in short-term visual acuity was observed. Although DME requires long-term treatment, it may be a low cost therapeutic option used in specific short-term situations.Trial registration: NCT03608839 (http://www.clinicaltrials.gov).
RESUMO
PURPOSE: To determine the efficacy of topical ketorolac tromethamine in preventing cystoid macular edema (CME) after uncomplicated cataract surgery. METHODS: This single-center, prospective, double-masked, randomized clinical trial consisted of 81 patients who were scheduled for cataract surgery. Patients were randomized to receive hypromellose/dextran 70 as a placebo (n=44) or ketorolac tromethamine 0.4% (n=37) as an adjuvant therapy. These eye drops were administered 4 times daily (QID) for 3 days before surgery and 5 weeks postoperatively. All patients received prednisolone acetate 1% QID during the same period as basal/standard anti-inflammatory therapy. The primary outcome was the incidence of angiographic CME 5 weeks after surgery. The secondary outcomes were mean change in best-corrected visual acuity (BCVA) [Early Treatment Diabetic Retinopathy study (ETDRS)], clinical CME incidence, intraocular pressure, and retinal thickness measured using optical coherence tomography (OCT). RESULTS: In the placebo group, 2/44 (4.5%) patients and in the ketorolac group, 2/37 (5.4%) patients presented with angiographic CME (P=0.624). The mean change in postoperative BCVA was 32±15 letters in the placebo group and 26±16 letters in the ketorolac group (P=0.07). There were no statistically significant between-group differences in the mean central subfield thickness (P=0.679), minimal central thickness (P=0.352), or central macular volume (P=0.729). CONCLUSION: There was no difference between ketorolac tromethamine and a placebo with regard to BCVA results or prevention of CME after uncomplicated cataract surgery.