Exploring the safety and feasibility of intracameral Aprokam® (cefuroxime sodium) in pediatric cataract surgery.

PURPOSE: To describe the safety and assess the feasibility of using intracameral cefuroxime sodium (Aprokam®) during congenital cataract surgery as a preventive measure for endophthalmitis.

DESIGN

Monocentric, prospective, observational pilot study.

SETTING

San Giuseppe Hospital, University of Milan, Milan, Italy.

STUDY POPULATION: Pediatric patients with a mean age of 21.4 ± 40.52 weeks with congenital cataracts. 65 eyes from 65 patients, i.e. only one eye for each patient was included in the study. At the end of the surgery, patients received the administration of intracameral Aprokam. The efficacy endpoint was assessed by excluding postoperative intra-ocular infections, while the safety endpoint was assessed by recording vital signs (body temperature, heart rate, blood pressure, respiratory rate) and local effects (corneal edema, toxic anterior segment syndrome, presence of cells or fibrin formation in anterior chamber, intraocular pressure, conjunctival hyperemia) after the administration of the substance.

RESULTS

Aprokam intracameral administration at the end of the cataract surgery prevented the occurrence of intraocular infection in all of our patients. Among the analyzed systemic parameters, breath frequency was the only one showing a statistically significant increase after the drug delivery (∆(post-pre) 0.4 breaths/minute ± 1.74; p = 0.022). Regarding the local adverse effects, a statistically significant increase of intraocular pressure has been detected from the first week (∆7 days-1 day: 0.9 mmHg ± 2.28, p = 0.042), and remained constantly elevated in the first month. The presence of conjunctival hyperemia noticed in the first week after surgery showed a significant decrease over time, with a statistically significant reduction after one month (8 cases vs 0, p = 0.009).

CONCLUSIONS

Intracameral administration of Aprokam in pediatric cataract surgery appears safe and promising as a preventive measure for post-operative endophthalmitis. It may be considered suitable for an optimal post-operative management of intra-ocular post-operative infections in congenital cataract surgery.