Safety and Efficacy of 0.1% Nepafenac versus 1% Prednisolone Acetate Eye Drops after Laser Peripheral Iridotomy: A Prospective, Randomized Trial.

PURPOSE: To compare 0.1% nepafenac, a topical nonsteroidal anti-inflammatory drop, with 1% prednisolone acetate in controlling inflammation after neodymium:yttrium-aluminum-garnet laser peripheral iridotomy (LPI) in primary angle-closure suspects (PACS).

DESIGN

Randomized controlled trial.

PARTICIPANTS

One hundred fifty-two PACS undergoing bilateral LPI.

METHODS

Patients were randomized to 0.1% nepafenac or 1% prednisolone acetate eye drops in both eyes. Medications were given 4 times daily for 7 days, then twice daily for additional 7 days. Investigators were masked to the type of medication. Right eyes in patients with bilateral PACS and the PACS eye in asymmetrical disease (primary angle closure in fellow eye) were analyzed.

MAIN OUTCOME MEASURES: Noninferior control of inflammation, defined as absence of cell in the anterior chamber at 2 weeks and absence of rebound iritis with medication discontinuation, was the primary outcome, whereas difference in the rise in intraocular pressure (IOP) was a secondary outcome.

RESULTS

Both groups were comparable in baseline characteristics, including IOP and total laser energy. Nepafenac was noninferior to prednisolone with regard to inflammation control, with 1 nepafenac-treated eye (1.3%) not meeting the primary end point because of 1+ anterior chamber cell at 2 weeks and 4 prednisolone-treated eyes (5.4%) failing to meet the primary end point because of rebound iritis (P < 0.001). A greater increase in IOP from baseline to 2 weeks was observed in the prednisolone group compared with the nepafenac group (+2.6 mmHg vs. +0.6 mmHg; P = 0.004), although at 4 weeks, IOP was not significantly different than baseline in either group (P > 0.05 for both). Two weeks after LPI, 3 nepafenac-treated eyes and 10 prednisolone-treated eyes demonstrated a 6- to 15-mmHg IOP elevation from baseline (P = 0.10), whereas 2 prednisolone-treated eyes and no nepafenac-treated eyes showed IOP elevation of more than 15 mmHg (P = 0.20). Four weeks after LPI, more prednisolone-treated eyes showed IOP elevation of 6 to 15 mmHg as compared with nepafenac-treated eyes (6 eyes vs. 1 eye; P = 0.04); no eyes showed IOP elevation of more than 15 mmHg.

CONCLUSIONS

Nepafenac was noninferior to prednisolone in controlling inflammation after LPI in PACS.