[Efficacy and efficiency of preoperative mydriasis: drops versus ocular insert].

OBJECTIVE: The primary objective of this study was to compare eye drops and inserts in terms of the quality of preoperative mydriasis. The secondary objective was to evaluate the safety and ease of use of each modality. PATIENTS AND METHODS: Prospective randomized and simple blinded study. Patients were randomized into two groups: the insert protocol (atropine 1%, diclofenac 0.1% collyrium and Mydriasert) or the eye drop protocol (atropine 1%, diclofenac 0.1%, tropicamide 0.5%, and phenylephrine 10% collyrium). Fifty-one patients were included: 25 in the insert protocol and 26 in the drop protocol. Mydriasis quality was evaluated by nurses and surgeons. The ease of use was estimated by the number of gestures required to obtain mydriasis and the difficulties encountered. Safety was evaluated at the patient's bedside.
RESULTS: Mydriasis of at least 6 mm was obtained in 92% of the patients in the insert protocol (23/25) and 85% of the patients in the drop protocol (22/26) (NS). Four patients lost their insert during the study. Of the patients in the insert group, 16% (4/25) experienced stinging in their eyes, as did 23% (6/26) of patients in the group using drops (NS). To reach effective mydriasis, the insert protocol required fewer nurse gestures per patient than the drop protocol (3.0 versus 8.3; p<0.001).
CONCLUSION: With the protocol using an insert, preoperative mydriasis is not inferior to that obtained with drops only and is more efficient in terms of nurse time and number of gestures. Nurses should be trained in appropriate handling of the insert and avoiding the loss of the device.

RCT Entities:   Population Interventions Outcomes