Speaker: Winston D Chamberlain MD, PHD, Oregon Health & Science University
Session: Should We Still Be Doing DSAEK?
What is DETECT Trial?
DETECT stands for Descemet Endothelial Fitness Comparison Trial and Detect is the first randomized controlled doubled mast clinical trial examining differences between Ultrathin DSAEK and DMEK and our primary outcome was six months. So in six months we wanted to determine best Spec Corrected ETDRS visual acuity.
What is the patient population?
Our trial in role the most common patient that requires endothelial keratoplasty in United States and that’s so that was 96% of our patients in the trial. There was a single patient with PBK in each of our cohorts. We enrolled a total of 50 of eyes that were randomized. So 25 ultrathin to DSAEK and 25 to DMEK. And the study was powered to detect a 1.2 snellen line difference between the two at six months and so our prior analysis suggested that we had enough statistical power in our patient population to do that.
What was the primary outcome?
The primary outcome of the study was a six month ETDRS visual acuity and we determined at three months already there was a significant difference between visual acuity and DMEK and ultrathin DSAEK with DMEK exceeding ultrathin DSAEK by 1.5 lines, a p-value of 0.002 which is highly significant. The six months data was even more impressive. DMEK continued to improve over ultrathin DSAEK, our p-value in that situation was a 0.001 and that’s a 1.7 line of improvement of DMEK.
Were there adverse events?
Winston D Chamberlain: So there was no significant difference when you take all those adverse outcomes as a whole. There was also no significant difference if we statically analysis each adverse outcome individually. We did see higher re-bubble rates with DMEK and this is a known process after the med surgery those [indiscernible] [00:02:10] tend to peel but it edges. We would like to see that re-bubble rate reduced. But actually even in our analysis it wasn’t a significant difference from our ultrathin DSAEK groups.
What are your conclusions from the trial?
So, I think the take home message for the study is that with such a profoundly significant improvement in visual acuity both early on and continuing to improve over a six month period, the DMEK is probably going to end up being our go to surgery for patients with primary endothelial dysfunction. One of the concerns that arises when we look at this kind of data is that there is a lot of very difficult eyes that we deal with and cornea eyes that have significant anterior segment pathology and placomo, they have damaged IRIS’s. They have secondary eye wells, they have been vitrectomized so they’ve been through multiple surgeries and we’re not sure that the results from this trial will translate for all those more difficult eyes.
And historically, we still have been doing the stake on those eyes because they are very challenging to do DMEK on. So we are thinking as we think through the results of this data and the compelling idea that DMEK does give superior visual acuity that we probably need to develop new surgical tools and standardized procedures to deal with DMEK and eyes with much more significantly complex Anatomy and significant pathology.