Intraoperative dexamethasone intravitreal implant in diabetic macular edema patients undergoing phacoemulsification: The CataDex study

Purpose To assess the impact of preoperative intravitreal dexamethasone implant (DexI) on functional and anatomic outcomes in patients with diabetic macular edema (DME) who underwent phacoemulsification cataract surgery. Methods Prospective and non-comparative study conducted on consecutive DME patients undergoing cataract surgery. DexI was administered 15 days before surgery and in a pro re nata regime after surgery. Main outcome measures were mean change in central retinal thickness (CRT), central subfield thickness (CST), total macular volume (TMV), and central subfield volume (CSV) from baseline to month-12. Secondary outcome was mean change in best corrected visual acuity (BCVA). Results Forty eyes were included in the study. CRT significantly decreased from 410.4 +/- 64.8 mu m at baseline to 303.2 +/- 24.3 mu m at month-12, p < 0.0001. Similarly, CST was significantly reduced from 436.4 +/- 120.4 mu m at baseline to 322.9 +/- 54.2 mu m at month-12, p < 0.0001. Total macular volume and CSV were significantly reduced from 9.95 +/- 1.68 mm3 and 0.38 +/- 0.11 mm(3) at baseline to 8.49 +/- 0.83 mm(3) and 0.31 +/- 0.05 mm(3) at month-12, respectively (p < 0.0001 each, respectively). BCVA significantly improved from 0.26 +/- 0.17 Snellen equivalent at baseline to 0.65 +/- 0.19 at month-12, p < 0.0001. Mean DexI administered during the study were 2.0 +/- 0.3. Neither DME subtype nor previous treatment status had any effect on functional or anatomic outcomes. Regarding safety, one (2.5%) eye developed ocular hypertension, which was successfully controlled with topical hypotensive treatment. Conclusions DexI was and effective and safe strategy for managing DME in diabetic patients undergoing uneventful cataract surgery.