Effect of Intracameral Injection of Preservative Free, Fixed Concentration of Combined Mydriatic plus Anaesthetic Formulation on Corneal Endothelial Cell Count in Phacoemulsification

Purpose: To evaluate the efficacy and safety of intracameral injection of a standardized combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% on corneal endothelial cell count at phacoemulsification. Methods: In this prospective randomized controlled study, 30 eyes of 30 patients undergoing phacoemulsification were assigned to 2 groups. 15 eyes (Intracameral Group A) received 0.2ml of a combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% just after the first incision. While 15 eyes (Group B) received a topical regimen of one drop of each of cyclopentolate hydrochloride 1% and tropicamide 1%, every 15min for 1hour preoperatively. The main outcome measures were safety on corneal endothelium, by comparing the preoperative and 3 weeks postoperative corneal endothelium cell count in the two groups. Efficacy was also evaluated by measuring pupil size before capsulorhexis and before intraocular lens implantation, in both groups. Results: There was no significant statistical difference in the percentage of endothelial cell loss between the Groups A (27.4%) and the reference Group B (25.7%), with P value (0.595). Regarding Pupillary dilatation, adequate dilatation (>7.4mm) was achieved in both groups. Dilatation was maintained to the end of operation in the Fydrane group, while in the reference group, reduction in pupillary dilatation occurred in 20% (3 cases) reaching pupil diameter 5.5mm before IOL implantation. Conclusions: This study showed that intracameral injection of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1% is safe on corneal endothelium and effective in maintaining pupillary dilatation throughout the surgery