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Marianne O Price, Theofilos Tourtas, Bjoern O Bachmann, Friedrich E Kruse, Francis W Price; Prospective, randomized comparison of different topical corticosteroid regimens in the first year following endothelial keratoplasty. Invest. Ophthalmol. Vis. Sci. 2014;55(13):874.
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To compare the efficacy and side effects of topical prednisolone acetate 1% vs. fluorometholone 0.1% following Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids are used routinely long-term to prevent cornea transplant rejection, but the clinical trials leading to drug approvals only evaluated short-term use. This is the first prospective randomized study to compare the efficacy and side effects of different corticosteroids for the critical first year post-transplant.
Subjects used prednisolone acetate 1% 4x/day for 1 month and then were randomized to continue with prednisolone or switch to fluorometholone. Dosing was 4x/day for 2 more months, 3x/day for 1 month, 2x/day for 1 month, and 1x/day to one year. The main efficacy outcome measure was the rate of corneal transplant rejection episodes, and the main safety outcome measure was the rate of intraocular pressure (IOP) elevation.
325 DMEK cases were randomized. Subjects were 98% Caucasian and 96% were treated for Fuchs’ dystrophy. The overall rate of rejection episodes was <1% and did not differ significantly between the 2 steroid groups (P=0.16). The rate of intraocular pressure elevation was 21% in the prednisolone group vs. 7% in the fluorometholone group (P<0.0001), using a threshold of ≥24 mmHg absolute IOP or a relative increase of ≥10 mmHg over the baseline preoperative reading. With a higher threshold (IOP ≥ 30 mmHg), the rate of IOP elevation was 10% in the prednisolone group vs. 1.4% in the fluorometholone group (p=0.0022). Among the eyes randomized to prednisolone, 13 (8%) were changed to a lower strength steroid to manage IOP. Among those randomized to fluorometholone, 3 (2%) were changed to a higher strength steroid to treat inflammation.
This study showed that the rate of immunologic graft rejection episodes is remarkably low (<1%) after DMEK. The findings suggest that with DMEK the topical steroid strength can be reduced in most cases after the first month to lessen clinically significant side effects, such as intraocular pressure elevation, without significantly increasing the rate of graft rejection episodes.
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