Anti-inflammatory Efficacy for Prophylaxis of Cystoid Macular Edema (CME) After Phacoemulsification

Summary

To compare the anti-inflammatory efficacy of ketorolac of tromethamine 0.4% and nepafenac 0.1% eye drops for prophylaxis of cystoid macular edema (CME) after small-incision cataract extraction.

Timeline

Start

2013-08

Primary completion

2013-08

Completion

2014-02

Outcome

Missed primary endpoint

paper Used prophylactically after uneventful cataract surgery, non-steroidal anti-inflammatory drugs were not efficacious in preventing macular oedema compared with placebo. PMID 25385061 ↗

paper There was no statistically significant difference between the three groups in any measurement performed by spectral-domain OCT. PMID 25385061 ↗

Publications

• Results Shelsta HN, Jampol LM. Pharmacologic therapy of pseudophakic cystoid macular edema: 2010 update. Retina. 2011 Jan;31(1):4-12. doi: 10.1097/IAE.0b013e3181fd9740.
• Results Brar M, Yuson R, Kozak I, Mojana F, Cheng L, Bartsch DU, Oster SF, Freeman WR. Correlation between morphologic features on spectral-domain optical coherence tomography and angiographic leakage patterns in macular edema. Retina. 2010 Mar;30(3):383-9. doi: 10.1097/IAE.0b013e3181cd4803.
• Results Almeida DR, Johnson D, Hollands H, Smallman D, Baxter S, Eng KT, Kratky V, ten Hove MW, Sharma S, El-Defrawy S. Effect of prophylactic nonsteroidal antiinflammatory drugs on cystoid macular edema assessed using optical coherence tomography quantification of total macular volume after cataract surgery. J Cataract Refract Surg. 2008 Jan;34(1):64-9. doi: 10.1016/j.jcrs.2007.08.034.
• Tzelikis PF, Vieira M, Hida WT, Motta AF, Nakano CT, Nakano EM, Alves MR. Comparison of ketorolac 0.4% and nepafenac 0.1% for the prevention of cystoid macular oedema after phacoemulsification: prospective placebo-controlled randomised study. Br J Ophthalmol. 2015 May;99(5):654-8. doi: 10.1136/bjophthalmol-2014-305803. Epub 2014 Nov 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Ketorolac	Other / unclassified	0.4 %	Topical
Subject	Nepafenac	Other / unclassified	0.1 %	Topical

Indications