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The nepafenac punctal plug delivery system (N-PPDS) is an experimental L-shaped plug made of nonbiodegradable, preservative-free medical-grade silicone. It can deliver a sustained level of nepafenac for six weeks. This is a prospective, randomised, parallel-arm, double-masked, placebo-controlled, phase II pilot study carried out across three US sites. Patients undergoing unilateral cataract surgery were randomised into two groups. Thirty-eight patients had the N-PPDS versus 18 patients in the placebo punctal plug group. All punctal plugs were removed at 14 days postoperatively. Postoperative pain scores were significantly better in the study group at days one, three, seven and 14, although only about two-thirds of the N-PPDS group were pain free at days three and 14. Ocular pain scores were similar in the two groups by 14 days. A total of 98.2% of the plugs were retained for the duration of the study, and there were no problems with extrusion. This study showed progress in moving towards drop-less cataract surgery. However, patients did require topical antibiotic drops and only 51.7% were pain free throughout the study. Although better than the control group, a higher level of pain control and a completely drop-free alternative must be the ultimate goal.

Safety and efficacy of nepafenac punctal plug delivery system in controlling postoperative ocular pain and inflammation after cataract surgery.
Donnenfeld E, Holland E, Solomon K.
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Mahmoud Ahmed

Royal Liverpool University Hospital, UK.

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