Preliminary results of a multicenter prospective randomized controlled trial comparing ultra-thin and standard thickness Descemet's stripping automated endothelial keratoplasty (DSAEK)

Session Details

Session Title: Cornea Surgical I

Session Date/Time: Monday 15/09/2014 | 08:00-10:30

Paper Time: 08:18

Venue: Boulevard B

First Author: : M.Dickman THE NETHERLANDS

Co Author(s): :    J. Van Rooij   L. Remeijer   G. Van der Lelij   R. Wijdh   F. Van Marion   R. Nuijts

Abstract Details

Purpose:

To compare the effectiveness of pre-cut ultra-thin (UT) with pre-cut standard thickness DSAEK. Outcome measures included best corrected ETDRS visual acuity and endothelial cell density.

Setting:

The study took place in four academic medical centers in The Netherlands:University Eye Clinic Maastricht, Rotterdam Eye Hospital, University Medical Center Groningen and University Medical Center Utrecht. Donor corneas were pre-cut by the Euro Cornea Bank, Beverwijk,The Netherlands.

Methods:

Fifty-eight patients were randomly assigned to either standard-thickness or UT-DSAEK. Eligible participants were all 18 years or older with Fuchs endothelial dystrophy and no other vision limiting comorbidities. Exclusion criteria were previous corneal transplantation in the study eye and HLA-typed transplantation. Randomisation criteria included EDTRS best-corrected-visual-acuity (BCVA), preoperative recipient central corneal thickness, age and center. Donor corneas were pre-cut using the Gebauer SLc microkeratome system. Lamellar thickness was measured using ocular-coherence-tomography, followed by ECD evaluation. Patients were evaluated preoperatively, 3-months, 6-months and 1-year postoperatively. BCVA was measured using a standardized ETDRS chart and ECD was manually measured by specular microscopy.

Results:

Mean patient age was 71±10 years. Mean lamellar thickness measured 95±30µm (95%C.I. 83-100) in the UT group and 217±34µm (95%C.I. 203-231) in the standard group. Preoperatively, BCVA did not differ between both groups (0.35±0.2logMAR, p=0.93). Three months postoperatively, BCVA was significantly better in the UT group (0.11±0.1logMAR) compared with the standard group (0.28±0.1logMAR, p<0.001). BCVA remained significantly better in the UT group (0.07±0.06logMAR) at 6 months compared with the standard group (0.26±0.11logMAR, p<0.001). ECD did not differ between groups at all time points and measured 2667±143 cells/mm2 preoperatively, 1523±224 cells/mm2 at 3 months and 1483±226 cells/mm2 at 6 months.

Conclusions:

The preliminary outcomes of our randomized controlled trial indicate that BCVA following pre-cut UT-DSAEK improves faster and remains significantly higher compared with standard pre-cut DSAEK with a similar endothelial cell loss. We expect these results to be generally applicable in the clinical setting to the benefit of patients.

Financial Interest:

One or more of the authors... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented