Efficacy and safety of a 3-month loteprednol etabonate 0.5% gel taper for routine prophylaxis after photorefractive keratectomy compared to a 3-month prednisolone acetate 1% and fluorometholone 0.1% taper

Abstract

PurposeTo compare the outcome of photorefractive keratectomy (PRK) and complications in patients treated with either loteprednol etabonate 0.5% gel or prednisolone acetate 1% suspension and fluorometholone (fml) 0.1% suspension.SettingJohn A Moran Eye Center, University of Utah, Salt Lake City, UT, USA.DesignProspective, randomized, partially masked trial.MethodsPRK was performed on 261 eyes of 132 participants. Patients were randomized to a postoperative corticosteroid regimen of either loteprednol etabonate 0.5% gel (loteprednol) or prednisolone 1% acetate suspension followed by fluorometholone 0.1% suspension (prednisolone/fml). Primary outcome measures included incidence and grade of postoperative corneal haze and incidence of increased intraocular pressure of 10 mmHg above baseline, or any intraocular pressure over 21 mmHg. Secondary outcome measures included uncorrected distance visual acuity, best corrected distance visual acuity, and manifest refraction spherical equivalent.ResultsThe incidence of haze in the first 3 months was 2.6% (3/114 eyes) in the loteprednol group and 4.8% (7/147 eyes) in the prednisolone/fml group and was not statistically significant between groups (P=0.37). The incidence of elevated intraocular pressure was 1.8% (2/114 eyes) in the loteprednol group and 4.1% (6/147 eyes) in the prednisolone/fml group, and was not statistically significant between the groups (P=0.12). The mean 3-month postoperative logMAR uncorrected visual acuity was −0.078±0.10 and −0.075±0.09 in the loteprednol and prednisolone/fml groups, respectively (P=0.83).ConclusionPostoperative corneal haze and elevated intraocular pressure were uncommon in both treatment arms. There was no statistically significant difference between each postoperative regimen. Refractive results were similar and excellent in both treatment arms. A tapered prophylactic regimen of loteprednol 0.5% gel is equally effective to prednisolone 1%/fml 0.1% after PRK.

Loteprednol etabonate for inflammatory conditions of the anterior segment of the eye: twenty years of clinical experience with a retrometabolically designed corticosteroid

“…No increase from baseline in mean IOP was observed in either LASIK or PRK eyes postoperatively (P ≥ 0.33), and IOP elevations ≥10 mm Hg were observed in only 2 of 108 PRK patients (1.9%). More recently, LE 0.5% gel was evaluated in an investigator-masked study in 132 patients (262 eyes) undergoing PRK randomized to one of the following regimens: (1) LE 0.5% gel QID for the first week, TID for three weeks, BID for one month, then QD for one month; or (2) PA 1% QID for one week, then BID for three weeks, then switched to fluorometholone 0.1% suspension given TID for one month, BID for one month, then stopped [62]. Over the 3-month postsurgical follow-up, the incidence of haze was similar between the LE (2.6%) and PA/fluorometholone (4.8%) groups (P = 0.43).…”

“…The combination of efficacy and safety often renders a 'smart steroid' designation, while efficacy purported to be less than other steroids such as difluprednate somewhat inaccurately recalls the 'soft steroid' moniker, a label originally coined to reflect better safety. In reality, as demonstrated in both tightly controlled animal model experiments and human trials, LE performs with admirable potency for a variety of indications compared to other topical steroids [20,33,45,[47][48][49][50]52,[62][63][64], the nonsteroidal anti-inflammatory ketorolac [44], and tCSA [36,65]. However, the rapid metabolism responsible for the improved safety of LE could result in slightly lower efficacy relative to other corticosteroids in cases of particularly severe, acute inflammation as suggested by one of two studies in acute anterior uveitis [33].…”

The effect of loteprednol suspension eye drops after corneal transplantation

“…Loteprednol suspension eye drops can penetrate the cornea and travel to the intraocular tissues more efficiently than prednisolone acetate eye drops since they possess esters instead of ketones at the C20 position, which is highly lipophilic, and their affinity with glucocorticoid receptors is 4.3 times that of dexamethasone [3,5]. Loteprednol suspension eye drops are used in the treatment of cataracts [6], corneal refractive surgery [7,8] inflammation after corneal transplantation [4], vernal keratoconjunctivitis [9], blepharoconjunctivitis [10] and uveitis [11].…”

How to Accelerate Very Early Recovery of Small Incision Lenticular Extraction Formyopia

“…The use of topical 0.1% fluorometholone has shown a faster resolution of post-operative symptoms and reduction of the very early inflammatory and wound healing responses after Small incision lenticule extraction 6 .This study aimed to investigate the impact of 0.1% fluorometholone in different defined daily dose systems of 0.1% fluorometholone in the very early phase (within 2h) after Small incision lenticule extraction. Visual acuity and a series of visual quality-related indexes were evaluated at 2, 4 and 24h postoperatively.…”