Effect Of Preoperative Use Of Topical Anti-inflammatory Prednisolone Acetate, Ketorolac Thrometamine, Nepafenac And Placebo, On The Maintenance Of Intraoperative Mydriasis In Cataract Surgery: A Randomized Controlled Trial

Abstract

 

Purpose:

 

To compare the effects of preoperative use of topical anti-inflammatoryprednisolone acetate, ketorolac thrometamine, nepafenac andplacebo, on the maintenance of intraoperative mydriasis in cataractsurgery.

 

Methods:

 

This was a masked, single-center, randomized clinical studycomprised 140 patients undergoing phacoemulsification cataractsurgery. Patients were randomized to receive either placebocarboxymethylcellulose sodium 0.5%, prednisolone acetate 1%,ketorolac thrometamine 0.4% or nepafenac 0.1%. Theses dropswere administered 48 hours before surgery in a mask fashion.Digital photos of the pupil were taken preoperatively, at thebeginning of the surgery, and post-operatively, immediatelyat the end of the surgery. The magnification was done previouslyby placing a millimeter scale under the microscope. The primaryendpoint was to measure the efficacy of each medication to inhibitmiosis (to achieve pupils > 6mm at the end of the surgery).The secondary outcome was to achieve pupils > 6mm at thebeginning of the surgery.

 

Results:

 

The comparison of the prednisolone, nepafenac and thrometaminegroups with the placebo group was statistically significant(p<0.005) in the maintenance of intraoperative mydriasis.All the patients to achieve preoperative mydriasis > 6mmat the beginning of the surgery.

 

Conclusions:

 

Prophylactic use of ketorolac, prednisolone and nepafenac waseffective in maintaining intraoperative mydriasis and can beused in surgical practice with similar effectiveness.  

 

 

Clinical Trial:

 

http://www.clinicaltrials.gov NCT00865540

 

Keywords: cataract • corticosteroids