Ocular Sticks for Routine Ophthalmic Surgery: A Randomized Controlled Monocentric Trial.

INTRODUCTION

Ocular sticks are used to absorb fluids during ophthalmic surgeries. Hence, this prospective study was conducted to evaluate the clinical performance, safety, and usability of Pro-optha Ocular Sticks in comparison to an alternative device under the conditions of routine ophthalmic surgeries.

METHODS

Patients requiring eye surgery were randomly allocated into two equal groups, with the investigational device, Pro-ophta Ocular Sticks, as the intervention group (IG) and the alternative stick as the comparator group (CG). Two types of surgery were performed. The study is also registered on the German Clinical Trials Register with ID DRKS00025690.

RESULTS

106 patients were included in the analyses. In both treatment groups, the investigator's/surgeon's general user satisfaction was rated as either "good" or "very good." The non-inferiority hypothesis that the Pro-ophta Ocular Stick is not rated worse in satisfaction than the alternative device was confirmed with statistical significance (p = 0.0005). At least 98.12% were rated as "good" and "very good" in both treatment groups for the additional endpoints. Pro-ophta Ocular Stick was rated better for almost all the additional endpoints and within the surgery subgroups. The mean number of sticks and surgery duration were 3.5 ± 2.74 and 11.5 (± 8.88) min, respectively, with a positive correlation (r = 0.580) for the Pro-ophta Ocular Stick and 3.9 ± 2.45 and 9.5 (± 5.90) min, respectively, with a positive correlation (r = 0.025) for the alternative device. No device-related adverse events occurred.

CONCLUSIONS

Effective ocular sticks play an instrumental role in the outcome of ophthalmic surgeries. The investigational device demonstrated efficiency, yielding good surgical results, usability, and an exceptionally good safety profile.