Abstract
PURPOSE: To evaluate the efficacy and safety of a hinged pupil expansion device (PED) in eyes with small pupils undergoing phacoemulsification. METHODS: In this prospective, multicenter, interventional case series of 57 eyes with suboptimal pharmacologic pupil dilation (<5 mm diameter), a hinged PED (I-Ring, Beaver-Visitec International, Waltham, MA) was applied to facilitate surgical visualization during cataract surgery. The pupil diameters (PD) were measured at different stages of the procedure and at the 1-month follow-up visit. Rate of successful intraoperative PED deployment, pupil size, and shape were assessed. RESULTS: The mean patient age was 70.5 ± 12.1 years. The I-Ring PED was successfully applied in all eyes. The mean PD at various stages were 4.1 ± 1.1 mm (dilation with eye drops only preoperatively), 4.3 ± 1.1 mm (dilation after intracameral epinephrine and ophthalmic viscoelastic device), 6.80 ± 0.00 mm (with PED applied), and 5.7 ± 1.1 mm (end of surgery). A statistically significant difference (P < 0.001) was observed between the mean PD with intracameral medications and with PED application. Postoperative circular pupil was observed in 54 of 57 eyes (94.7%) and the mean eccentricity index (n = 57 eyes) was 0.11 ± 0.22. No significant adverse events were observed. CONCLUSION: The I-Ring PED safely and effectively provided and maintained adequate pupil expansion and surgical visualization in eyes with small pupils undergoing cataract surgery. Postoperatively 95% of eyes attained circular pupils. This hinged PED is an additional instrumentation option for the safe and effective expansion of inadequately sized pupils during cataract surgery.