Prophylactic nepafenac and ketorolac versus placebo in preventing postoperative macular edema after uneventful phacoemulsification.
OBJECTIVE
To evaluate the efficacy of prophylactic ketorolac 0.5% versus nepafenac 0.1% versus placebo on macular volume 1 month after uneventful phacoemulsification and evaluate the health-related quality-of-life (HRQOL) of topical nonsteroidal antiinflammatory drugs (NSAIDs) in the context of cataract surgery.


METHODS
Hotel Dieu Hospital, Kingston, Ontario, Canada.


METHODS
Prospective placebo-controlled parallel-assignment double-masked randomized clinical trial.


METHODS
In this study, patients 18 years or older scheduled for routine phacoemulsification were randomized to a placebo, ketorolac 0.5%, or nepafenac 0.1% and dosed 4 times a day starting 1 day before surgery and continuing for 4 weeks. Spectral-domain macular cube ocular coherence tomography scans measuring central subfield thickness, macular cube volume, and average macular cube thickness were performed at baseline and 1 month postoperatively. The HRQOL metrics were determined with the Comparison of Ophthalmic Medications for Tolerability (COMTOL) questionnaire.


RESULTS
Each study group comprised 54 patients. One month postoperatively, although a trend toward significance occurred for nepafenac and ketorolac, analysis of the means of differences showed no statistically significant differences between the 3 study groups (P=.2901). The COMTOL analysis found no difference in tolerability, compliance, side-effect frequency and bother, and effects on HRQOL between ketorolac and nepafenac compared with the placebo.


CONCLUSIONS
One month after uneventful phacoemulsification, there was no difference in macular volume between the placebo, ketorolac, and nepafenac. Ketorolac and nepafenac were well tolerated with minimal side-effect profiles. Thus, for patients without risk factors having routine surgery, prophylactic topical NSAIDs are not recommended.
Department of Ophthalmology, Queen's University, Hotel Dieu Hospital, Kingston, Ontario, Canada. dalmeida@evolation-medical.com
David R P
DR
Almeida
Zainab
Z
Khan
Lin
L
Xing
Shahrukh N
SN
Bakar
Karim
K
Rahim
Todd
T
Urton
Sherif R
SR
El-Defrawy
D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D044482:Benzeneacetamides / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D006304:Health Status; D006801:Humans; D020910:Ketorolac / Q000008:administration & dosage* / Q000009:adverse effects; D008269:Macular Edema / Q000175:diagnosis / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D018918:Phacoemulsification; D010648:Phenylacetates / Q000008:administration & dosage* / Q000009:adverse effects; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D041623:Tomography, Optical Coherence; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D044482:Benzeneacetamides; D009883:Ophthalmic Solutions; D010648:Phenylacetates; C414203:nepafenac; D020910:Ketorolac