Incidence of pseudophakic cystoid macular edema in eyes with and without pupil expansion device.

Purpose: Novel pupil expansion devices are widely recognized for their intraoperative feasibility in safe small pupil cataract surgeries. To assess whether the use of pupil expansion devices affects recovery from cataract surgery.

Methods: A post hoc analysis of five consecutive prospective randomized clinical trials. 536 eyes of 536 patients undergoing routine cataract surgery were analysed according to the use of pupil expansion device. Thirty-four eyes were operated with pupil expansion device and 502 eyes without. Clinical outcome parameters were recorded at 28 days and 3 months.

Results: Patient age and gender distribution, and baseline clinical outcome parameters were comparable between study groups. Pseudoexfoliation syndrome, glaucoma and medication for benign prostatic hyperplasia were more frequently present; phacoemulsification energy was higher and operation time longer in eyes with pupil expansion device. At 28 days, aqueous flare increased by 12.0 ± 25.1 pu/mseconds and mean central subfield macular thickness by 16.2 ± 24.4 μm in eyes with pupil expansion device, when compared to 4.6 ± 14.8 pu/mseconds (p = 0.015) and 7.0 ± 33.9 μm (p = 0.064) in eyes without the device. At 3-month follow-up, clinically significant pseudophakic cystoid macular edema (PCME) was reported in 12% of eyes with pupil expansion device and in 2% of eyes without (p = 0.006). After adjusting for the presence of confounding factors, hazard for clinically significant PCME was greater in eyes with pupil expansion device than in those without (HR 5.41, 95% CI 1.35-21.71, p = 0.017).

Conclusions: The use of pupil expansion device may predispose eyes to increased risk of clinically significant PCME. Effective anti-inflammatory treatment and follow-up are warranted in eyes with pupil expansion device.