Efficacy and tolerability of preservative-free and preserved diclofenac and preserved ketorolac eyedrops after cataract surgery.
OBJECTIVE
To compare the anti-inflammatory efficacy and subjective tolerability of preservative-free and preserved diclofenac 0.1% and preserved ketorolac 0.5% eye drops for prophylaxis and management of inflammation after cataract surgery.


METHODS
Prospective, randomized, investigator-masked, parallel-group, comparative clinical trial.


METHODS
One hundred two patients who underwent small-incision phacoemulsification cataract surgery in an institutional setting were assigned randomly to receive preservative-free diclofenac sodium 0.1% (Voltaren ophtha SDU; Novartis Pharma), preserved diclofenac sodium 0.1% (Voltaren ophtha; Novartis Pharma), or preserved ketorolac tromethamine 0.5% (Acular; Pharm Allergan) eyedrops 4 times daily for 4 weeks after surgery. During the 1-month follow-up, anterior chamber flare and mean foveal thickness were evaluated for objective comparison of the anti-inflammatory effect. Ocular tolerability was assessed by observer-based grading of conjunctival hyperemia and ocular discomfort, as well as obtaining subjective ratings of ocular tolerability on a visual analog scale. Distance and near visual acuity and intraocular pressure served as safety measures.


RESULTS
All 3 formulations demonstrated equal anti-inflammatory efficacy as measured by reduction of anterior chamber flare after surgery and prevention of postoperative macular edema. Patients treated with preservative-free diclofenac eyedrops reported significantly better subjective tolerability values (P = .001), were classified as having less ocular discomfort (P < .001), and experienced earlier reduction of postoperative conjunctival hyperemia (P = .029).


CONCLUSIONS
Anti-inflammatory efficacy was comparable for all 3 agents. However, preservative-free diclofenac 0.1% eyedrops exhibited a significantly better postoperative subjective and objective tolerability when compared with preserved eyedrops containing ketorolac or diclofenac.
Department of Ophthalmology & Optometry, Medical University Vienna, Vienna, Austria.
Saskia M
SM
Maca
Michael
M
Amon
Oliver
O
Findl
Gunal
G
Kahraman
Talin
T
Barisani-Asenbauer
D000368:Aged; D000369:Aged, 80 and over; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D001548:Benzalkonium Compounds / Q000008:administration & dosage / Q000009:adverse effects; D004008:Diclofenac / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D020910:Ketorolac / Q000008:administration & dosage* / Q000009:adverse effects; D019654:Lens Implantation, Intraocular; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D017060:Patient Satisfaction; D018918:Phacoemulsification; D011183:Postoperative Complications / Q000517:prevention & control*; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D014792:Visual Acuity / Q000502:physiology
D000894:Anti-Inflammatory Agents, Non-Steroidal; D001548:Benzalkonium Compounds; D009883:Ophthalmic Solutions; D011310:Preservatives, Pharmaceutical; D004008:Diclofenac; D020910:Ketorolac