Original article
Efficacy and Tolerability of Preservative-Free and Preserved Diclofenac and Preserved Ketorolac Eyedrops After Cataract Surgery

https://doi.org/10.1016/j.ajo.2009.12.010Get rights and content

Purpose

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.

Design

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.

Section snippets

Methods

This prospective, randomized, investigator-masked, parallel-group, open-label, comparative, 4-week trial was conducted from July 2005 through February 2008 in an institutional setting at the Department of Ophthalmology and Optometry, Medical University of Vienna. One hundred two consecutive patients scheduled for phacoemulsification cataract surgery with implantation of a posterior chamber intraocular lens were enrolled in the study. Baseline patient characteristics are given in the Table.

Results

Of the 102 subjects enrolled and randomized, 34 eyes were assigned to each of the 3 treatment groups. Ninety-three patients, 31 of the preservative-free diclofenac group (91.2%), 29 of the preserved diclofenac group (85.3%), and 33 of the preserved ketorolac group (97.1%) completed the study (Figure 1). Seven patients were lost to follow-up (1 had urgent orthopedic surgery and 6 did not appear for follow-up and declined an additional visit despite contact by telephone), and 2 patients had to be

Discussion

Although all NSAIDs inhibit the cyclooxygenase pathway, diclofenac additionally inhibits the lipoxygenase pathway.5, 6, 18 This unique quality of diclofenac gives it a spectrum of activity more similar to corticosteroids and gives expectations for an increased anti-inflammatory efficacy. However, in an animal model of ocular inflammation, topical ketorolac exhibited greater anti-inflammatory effects than diclofenac and loteprednol.19 Several studies in human eyes have shown topical diclofenac

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