Publication:

A study on effect of pre-operative topical prednisolone acetate, nepafenac and placebo, on intraoperative mydriasis and its sustenance during cataract surgery: a randomized trial

Background The objective of the current study was to study the effects of pre-operative use of topical anti-inflammatory prednisolone acetate, nepafenac and placebo, on the sustenance of intraoperative mydriasis during cataract surgery.

Methods This study comprised of 60 patients scheduled for cataract surgery. Patients (20 in each group) were randomized to receive placebo, prednisolone acetate, and nepafenac. These eye drops were given 3 times daily for the 2 days prior to surgery. The pupillary diameters were measured by the surgeon using Casterveijo’s Caliper before the corneal section and at the end of surgery. The primary result was the number of patients with pupil ≥6 mm at the end of the surgery; the secondary result was the number of patients with pupil ≥6 mm at the beginning of the surgery. It was a single-center, masked, randomized clinical study.

Results All the patients achieved pupil ≥6 mm at the beginning of the surgery. The number of patients in the prednisolone (16/20) and nepafenac (17/20) groups with pupil ≥6 mm was greater than in the placebo group in the maintenance of intraoperative mydriasis (7/20 – p=0.003). There was no statistically significant difference among the prednisolone and nepafenac groups in the maintenance of intraoperative mydriasis (p=0.791). There were no complications during surgery or related to the pre-operative use of the eye drops.

Conclusion Pre-operative use of prednisolone acetate and nepafenac was effective in maintaining the intraoperative mydriasis when compared with placebo.