Effect of preoperative use of topical prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery: A randomized trial

Abstract

Purpose:To compare the effects of preoperative use of topical anti-inflammatory prednisolone acetate, ketorolac tromethamine, nepafenac and placebo, on the maintenance of intraoperative mydriasis during cataract surgery.Design:Randomized clinical trial.Materials and Methods:This single-center, masked, randomized clinical study comprised 140 patients scheduled for cataract surgery. Patients (35 in each group) were randomized to receive placebo, prednisolone acetate, ketorolac tromethamine 0.4% or nepafenac. These eye drops were administered three times daily for the two days prior to surgery. The pupillary diameters were measured by the surgeon using a compass prior to the corneal section and at the end of surgery. The primary outcome was the number of patients with pupil ≥ 6mm at the end of the surgery; the secondary outcome was the number of patients with pupil ≥ 6mm at the beginning of the surgery.Results:All the patients achieved pupil ≥ 6mm at the beginning of the surgery. The number of patients in the prednisolone (29/35), nepafenac (31/35) and ketorolac (30/35) groups with pupil ≥ 6mm was greater than in the placebo group in the maintenance of intraoperative mydriasis (19/35 – P =0.003). There was no statistical difference among the prednisolone, nepafenac and ketorolac groups in the maintenance of intraoperative mydriasis (P =.791). There were no complications during surgery or related to the preoperative use of the eye drops.Conclusion:Preoperative use of ketorolac, prednisolone and nepafenac was effective in maintaining intraoperative mydriasis when compared with placebo.

Non-steroidal anti-inflammatory drugs versus corticosteroids for controlling inflammation after uncomplicated cataract surgery

“…Some studies included a group of participants who received other types of cataract surgery, in which case we used only the data from the participants who underwent phacoemulsification. The studies were conducted in 17 different countries: three in Brazil (Ticly 2014; Tzelikis 2015; Zanetti 2012), two in Canada (Almeida 2008; Almeida 2012), four in China (Chen 2015; Li 2011; Wang 2013; Zhang 2008), one in Cuba (Ruiz Rodríguez 2011), one in Egypt (Elsawy 2013), one in France (Adam 2005), two in Germany (Hessemer 1996; Schmitt 1995), two in Greece (Chatziralli 2011; Moschos 2012), one in India (Sahu 2015), one in Iran (Entezari 2016), seven in Japan (Asano 2008; Endo 2010; Kato 1998; Miyake 2007; Miyake 2011; Miyanaga 2009; Shimazaki 1996), one in Mexico (Cervantes-Coste 2009), one in South Korea (Jung 2015), two in Sweden (Laurell 2002; Zaczek 2014), one in Thailand (Trinavarat 2003), two in Turkey (Dal 2014; Yavas 2007), and seven in the United States (Duong 2014; el-Harazi 1998; Holzer 2002; Mathys 2010; Singh 2012; Solomon 2001; Wittpenn 2008). Investigators of nine studies did not report in which country the trial had been conducted (Bucci 2001; Demco 1997; Donnenfeld 2006; Guzey 2000; McColgin 1999; Mulet 2001; Ostrov 1997; Roberts 1995; Voudouri 2002).…”

“…Nineteen studies compared a combination of an NSAID plus a corticosteroid with a corticosteroid only (Adam 2005; Almeida 2008; Cervantes-Coste 2009; Chatziralli 2011; Chen 2015; Dal 2014; Elsawy 2013; Entezari 2016; Li 2011; Mathys 2010; McColgin 1999; Moschos 2012; Ruiz Rodríguez 2011; Shimazaki 1996; Singh 2012; Ticly 2014; Wittpenn 2008; Zaczek 2014; Zhang 2008). Fourteen other studies had three or more arms and had such combinations as an NSAID alone versus a corticosteroid alone versus a combination (Hessemer 1996; Miyanaga 2009; Schmitt 1995); multiple NSAIDs compared with each other and versus a corticosteroid (el-Harazi 1998; Mulet 2001; Zanetti 2012); an NSAID versus a corticosteroid versus a different corticosteroid (Ostrov 1997; Trinavarat 2003); and multiple combinations of an NSAID plus a corticosteroid against each other with a corticosteroid-only arm in addition (Almeida 2012; Donnenfeld 2006; Jung 2015; Sahu 2015; Tzelikis 2015; Yavas 2007). NSAIDs given in the studies were indomethacin, ketorolac, nepafenac, diclofenac, bromfenac, flurbiprofen, and pranoprofen.…”

Comparison of the efficacy and patients’ tolerability of Nepafenac and Ketorolac in the treatment of ocular inflammation following cataract surgery: A meta-analysis of randomized controlled trials

“…Two studies [16, 23] described these two drugs’ influence on intraoperative mydriasis. The pooling result of a fixed-effect model ( P = 1.00, I 2 = 0%) manifested that there was no statistical difference between the Nepafenac and Ketorolac groups in the maintenance of intraoperative mydriasis (WMD = 0.000, 95%CI: - 0.355~0.355, P = 1.000, Fig 4).…”

Management of mydriasis and pain in cataract and intraocular lens surgery: review of current medications and future directions

“…Appropriate mydriasis during IOL exchange surgery is key to a successful surgical outcome 1. Impaired visualization through a small pupil increases the chance of tissue damage, retained nuclear material, and vitreous loss 17,18.…”

“…Options include, but are not limited to, ketorolac, nepafenac, flurbifrofen, and prednisolone. There is evidence that preoperative NSAIDs and/or steroid drops are effective in maintaining intraoperative mydriasis as compared to no other additional preoperative eye drops 1,52,53…”