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DMEK graft rejection rate low with prednisolone acetate or fluorometholone
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Descemet’s membrane endothelial keratoplasty yielded a low graft rejection rate at 1 year with the administration of prednisolone acetate 1% or fluorometholone 0.1%, according to a study.
The incidence of graft rejection after DMEK was insignificantly higher in patients who received fluorometholone than in those who received prednisolone acetate, the study authors said.
“[This] was the first prospective, randomized study to confirm the remarkably low rejection episode risk with DMEK that was previously observed in retrospective analyses,” Marianne O. Price, PhD, the corresponding author, told Ocular Surgery News.
The incidence of graft rejection associated with DMEK is typically 1% or less at 2 years. The study authors hypothesized that it may be possible to reduce topical corticosteroid strength without significantly increasing the incidence of graft rejection after DMEK.
“[Endothelial keratoplasty] has a lower risk of rejection than penetrating keratoplasty. And then DMEK, that particular type of endothelial keratoplasty, has the lowest rejection risk of any type of transplant,” Price said. “So, possibly, that might be influencing surgeons to cut back on steroid dosing, and we certainly hope that the results of our study encourage that trend.”
The study was published in Cornea.
Patients and procedures
The prospective, randomized open-label controlled trial included 325 eyes that underwent DMEK; 297 eyes (91%) completed the study.
The most common indication for DMEK was Fuchs’ dystrophy (96%). Twenty-nine eyes (9%) were previously diagnosed with glaucoma.
Patients used prednisolone acetate 1% four times daily for 1 month after DMEK and then were randomized 1:1 to use prednisolone acetate 1% (164 eyes) or fluorometholone 0.1% (161 eyes) from month 2 to month 12.
The dosing frequency for both study arms was four times daily in months 2 and 3 after DMEK, three times daily in month 4, twice daily in month 5 and once daily in months 6 to 12.
Fellow eyes of 61 patients were assigned to opposite treatment arms.
The investigators evaluated outcomes at 1, 3, 6 and 12 months postoperatively.
Primary outcome measures were immunologic rejection and IOP elevation defined as IOP of 24 mm Hg or higher or an increase of 10 mm Hg or greater from baseline.
Outcomes and observations
No eyes in the prednisolone acetate group and two eyes in the fluorometholone group (1.4%) had a graft rejection episode within 1 year. The between-group difference was insignificant. Both cases of rejection resolved with increased topical steroids.
“Graft rejection is an adaptive immune response. Corticosteroids are immunosuppressive, and they reduce inflammation. Basically, they’re just quieting down the immune response. Fortunately, with the eye, we can apply them topically right where you want it to be and not affect the rest of the body,” Price said.
Endothelial cell loss was similar in both groups at 1 year.
IOP exceeded the defined elevation threshold in 21.9% of eyes in the prednisolone acetate group and 6.1% of eyes in the fluorometholone group. The difference was statistically significant (P = .0005).
Glaucoma medications were initiated or increased in 17% of eyes in the prednisolone acetate group and 5% of eyes in the fluorometholone group (P = .0003).
“There is an order of magnitude difference in the concentration of those two ophthalmic solutions. The prednisolone acetate is a 1% solution … whereas the fluorometholone is a 0.1% solution. So, it’s 10 times weaker,” Price said.
Price noted that, in her husband’s practice, Francis W. Price Jr., MD, patients are started on a relatively strong steroid such as prednisolone acetate 1% and switched to a weaker steroid such as fluorometholone 0.1% at 2 months.
“We’ve already put the results into practice with our patients,” she said. “We feel like it is definitely the best with DMEK recipients to go ahead and reduce the steroid strength at 1 to 2 months.” – by Matt Hasson
Reference:
Price MO, et al. Cornea; 2014;doi:10.1097/ICO.0000000000000206.For more information:
Marianne O. Price, PhD, can be reached at Price Vision Group, 9002 N. Meridian St., Suite 100, Indianapolis, IN 46260; email: marianneprice@cornea.org.Disclosure: Price is director of the Cornea Research Foundation, which has received educational grants from Alcon and Allergan and a research grant from Bausch + Lomb.
Perspective
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Eric D. Donnenfeld, MD
Descemet’s membrane endothelial keratoplasty is an exciting new treatment for endothelial dystrophies and pseudophakic bullous keratoplasty. The procedure has not been widely adopted to date but is gaining traction as the superb return of visual acuity with low graft rejection is becoming widely recognized. In this study, the authors, who are innovators in this technique, performed a randomized trial of patients undergoing DMEK for Fuchs’ dystrophy comparing the conventional corticosteroid (prednisolone acetate 1%) vs. a milder corticosteroid (fluorometholone 0.1%). The main outcome measures are graft rejection and corticosteroid-induced glaucoma. The results of the trial show an extremely low graft rejection rate in both groups (although higher with fluorometholone 0.1%) and a significantly high rate of IOP problems with the stronger steroid (prednisolone acetate 1%). Based on the low rejection rate associated with DMEK, the need for a stronger corticosteroid may not be necessary and the increased safety profile of fluorometholone may be sufficient in low-risk cases of DMEK.
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