Efficacy and safety of femtosecond laser-assisted corneal endothelial keratoplasty: a randomized multicenter clinical trial.
BACKGROUND
To evaluate the efficacy and safety of femtosecond laser-assisted endothelial keratoplasty (FLEK) versus penetrating keratoplasty (PK) in patients with corneal endothelial disease.


METHODS
A randomized multicenter clinical trial of 80 eyes of 80 patients with corneal endothelial disease were randomized to FLEK or PK. Clinical outcomes (astigmatism and visual acuity) and incidence of postoperative complications were compared between the two groups.


RESULTS
At 12 months, the percentage of eyes with a refractive astigmatism less than or equal to 3 diopters was higher in the FLEK group in comparison with the PK group (86.2% vs. 51.3%, P=0.004). The mean postoperative best corrected visual acuity was 20/70+/-2 lines in the FLEK group and 20/44+/-2 lines in the PK group (P<0.001), but the gain in the best corrected visual acuity between the two groups was not significantly different. The endothelial cell loss in the FLEK and PK group was 65+/-12% and 23+/-15% (P<0.001). The most common postoperative complication in the FLEK group was graft dislocation (27.8%). Wound healing related problems occurred in six eyes (15%) in the PK group and in none of the FLEK eyes.


CONCLUSIONS
FLEK effectively reduces postoperative astigmatism and results in an absence of wound healing related problems in patients with endothelial disease. However, visual acuity is lower as compared with conventional PK, and the high level of endothelial cell loss warrants a modification of the insertion technique of the endothelial graft.
Cheng
Yanny Y Y
YY
Department of Ophthalmology, University Hospital Maastricht, Maastricht, The Netherlands.
Schouten
Jan S A G
JS
Tahzib
Nayyirih G
NG
Wijdh
Robert-Jan
RJ
Pels
Elisabeth
E
van Cleynenbreugel
Hugo
H
Eggink
Catharina A
CA
Rijneveld
Wilhelmina J
WJ
Nuijts
Rudy M M A
RM
D000368:Aged; D000369:Aged, 80 and over; D001251:Astigmatism / Q000209:etiology; D055954:Corneal Endothelial Cell Loss / Q000503:physiopathology / Q000601:surgery*; D048988:Corneal Surgery, Laser / Q000009:adverse effects; D057111:Descemet Stripping Endothelial Keratoplasty / Q000009:adverse effects; D004728:Endothelium, Corneal / Q000637:transplantation*; D005260:Female; D006801:Humans; D015948:Keratoplasty, Penetrating / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D013997:Time Factors; D016896:Treatment Outcome; D014792:Visual Acuity; D014945:Wound Healing