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Clifford Salinger, Michael Gordon, Mitchell Jackson, Eric D Donnenfeld; Retrospective Assessment of the Routine Use of Loteprednol Etabonate Gel 0.5% Following LASIK and PRK Surgery. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3932.
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© ARVO (1962-2015); The Authors (2016-present)
To assess real world experience using loteprednol etabonate ophthalmic gel, 0.5% (LE gel) for postoperative pain and inflammation following laser-assisted in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) surgery.
This was a retrospective chart review conducted at multiple centers in the United States. Cases from patients aged 18 years and above were eligible for inclusion. Data were collected from cases of routine LASIK or PRK surgery in which LE gel was used postoperatively as the clinician’s routine standard of care and in which patients were followed-up for up to 6 months. Data evaluated included refractive characteristics, intraocular pressure (IOP) measurements, LE gel dosing regimen, adverse events (AEs) and early discontinuations. The primary outcomes of interest included IOP changes, other AEs, and reasons for any early treatment discontinuation.
This analysis, representing data from 4 clinical sites to date, included 237 eyes (98, LASIK; 139, PRK) from 121 patients (mean age: LASIK, 35.2 years; PRK, 34.1 years). The most common post-operative dosing regimens for LE gel were QID for one week in LASIK patients, and a 4-week tapered dosing regimen (QID, TID, BID, QD, each for 1 week) in PRK patients. Depending on the site, postoperative treatment with LE gel was initiated either on the surgical day or first post-surgical day. Most patients received concurrent treatment with topical NSAIDs (primarily bromfenac or nepafenac) and antibacterials (besifloxacin or moxifloxacin). Mean (± SD) IOP decreased from 15.2 ± 2.3 mm Hg (range = 9-14 mm Hg) preoperatively to 14.1 ± 2.5 mm Hg (range, 9-21 mm Hg) in the LASIK cohort (P=0.0021) and from 14.8 ± 2.9 mm Hg (range, 7-26 mm Hg) preoperatively to 14.2 ± 3.9 mm Hg (range, 8-25 mm Hg) in the PRK cohort (P=0.2390). There were no IOP elevations ≥10 mm Hg or IOP measurements >25 mm Hg at any postoperative visit. Other than persistent corneal haze in a PRK patient prompting a temporary substitution of prednisolone for LE gel, there were no AEs attributed to LE gel in either cohort or early discontinuation of LE gel therapy. Most patients had a final visual acuity of 20/20 or better.
Based on real world experience, LE gel appears to have a high level of safety and tolerability when used for the management of postoperative pain and inflammation following LASIK and PRK surgery.
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