PURPOSE: Prospective randomized clinical trial to evaluate the efficacy of lyophilized corneas for deep anterior lamellar keratoplasty (DALK) in patients with keratoconus. METHODS: Ten eyes underwent DALK and received corneas that had been lyophilized, and 10 eyes received corneas kept in Optisol. Follow-up examinations included measurement of visual acuity (VA; Early Treatment Diabetic Retiropathy Study chart), topography, pachymetry, specular microscopy, contrast sensitivity, and confocal microscopy. RESULTS: All variables improved similarly in both groups, without statistical differences between them, except for the uncorrected VA in the sixth postoperative month, which was better in the lyophilized group (0.46) compared with the Optisol group (0.70). The best spectacle-corrected VA was 0.16 in the lyophilized group and 0.26 in the Optisol group. The mean endothelial cell count during the sixth postoperative month was 2778.5 in the lyophilized group and 2611.5 in the Optisol group. Optisol corneas had greater keratocyte density, and the keratocyte density improved in lyophilized corneas during follow-up. CONCLUSIONS: Lyophilized corneas can be used successfully for DALK to treat keratoconus with results similar to Optisol corneas.
RCT Entities:
PURPOSE: Prospective randomized clinical trial to evaluate the efficacy of lyophilized corneas for deep anterior lamellar keratoplasty (DALK) in patients with keratoconus. METHODS: Ten eyes underwent DALK and received corneas that had been lyophilized, and 10 eyes received corneas kept in Optisol. Follow-up examinations included measurement of visual acuity (VA; Early Treatment Diabetic Retiropathy Study chart), topography, pachymetry, specular microscopy, contrast sensitivity, and confocal microscopy. RESULTS: All variables improved similarly in both groups, without statistical differences between them, except for the uncorrected VA in the sixth postoperative month, which was better in the lyophilized group (0.46) compared with the Optisol group (0.70). The best spectacle-corrected VA was 0.16 in the lyophilized group and 0.26 in the Optisol group. The mean endothelial cell count during the sixth postoperative month was 2778.5 in the lyophilized group and 2611.5 in the Optisol group. Optisol corneas had greater keratocyte density, and the keratocyte density improved in lyophilized corneas during follow-up. CONCLUSIONS: Lyophilized corneas can be used successfully for DALK to treat keratoconus with results similar to Optisol corneas.