Abstract
Purpose: :
To compare the early visual results and postoperative recovery between two groups of keratoconic patients - one group having undergone a traditional, mechanical vacuum trephine procedure while the second group underwent femtosecond-enabled penetrating keratoplasty
Methods: :
Prospective, randomized study of 60 patients (60 eyes) with keratoconus. Exclusion criteria included different ocular pathology and a potential visual acuity of less than 20/40. The patients were randomized into two treatment groups: Group 1 - penetrating keratoplasty with femtosecond laser shaped incisions (IntraLase Enabled Keratoplasty [IEK]) (n=30); Group 2 - penetrating keratoplasty with vacuum trephine (n=30). Outcome measurements included best-corrected visual acuity, manifest refraction, biomicroscopy exam, intraocular pressure, corneal topography, pachymetry, optical coherence tomography, specular microscopy, and wavefront aberrometry. Patients were evaluated by a masked observer and will be followed out to 1 year at regular intervals
Results: :
At the time of this abstract, there were 30 manual and 30 IEK eyes available for review at 1 month postoperative. At this visit, the IEK group had a mean BCVA of 0.51(Snellen) vs. a mean pre-op BCVA of 0.17. The manual group had a mean BCVA of 0.36(Snellen) vs. a mean pre-op BCVA or 0.29. At the three-month postoperative visit, there were 24IEK eyes and 12 manual eyes available for analysis. The mean BCVA in the IEK eyes was 0.6 (Snellen) compared to a mean of 0.5 (Snellen) in the manual eyes. OCT analysis showed that the IEK transplants were well positioned with good healing. There are no differences between the two groups in specular microscopy, pachymetry and corneal topography. Three pacients from manual group had endothelial rejection. Full 6 month results will be presented
Conclusions: :
These preliminary results show that there is faster refractive stability, improved healing and greater stability in the IEK eyes. An added advantage of the IEK procedure is that there is less of a need to manipulate the corneal tissue during the transplantation process
Clinical Trial: :
www.clinicaltrials.gov 466-07
Keywords: transplantation • keratoconus