OBJECTIVE: To compare changes in subbasal nerve density and corneal sensitivity after laser in situ keratomileusis (LASIK) with the flap created by a femtosecond laser (bladeless) vs a mechanical microkeratome. DESIGN: In a randomized paired-eye study, 21 patients receivedmyopic LASIK with the flap created by a femtosecond laser in one eye and by a mechanical microkeratome in the fellow eye. Eyes were examined before and at 1, 3, 6, 12, and 36 months after LASIK. Central subbasal nerve density was measured by using confocal microscopy. Corneal mechanical sensitivity was measured by using a gas esthesiometer and was expressed as the ratio of mechanical threshold in eyes that received LASIK to mechanical threshold in concurrent control eyes. RESULTS:Subbasal nerve density and corneal sensitivity did not differ between methods of flap creation at any examination. Mean (SD) nerve density was decreased at 1 month (bladeless, 974 [2453] μm/mm(2); microkeratome, 1308 [2881] μm/mm(2)) compared with the preoperative examination (bladeless, 10,883 [5083] μm/mm(2), P < .001; microkeratome, 12,464 [6683] μm/mm(2), P < .001) and remained decreased through 12 months (P < .001). Mechanical threshold ratios did not differ from that at the preoperative examination through 36 months for either LASIK treatment; when all LASIK eyes were combined, the mechanical threshold ratio was transiently higher (decreased sensitivity) at 1 month (1.29 [0.85]) compared with the preoperative examination (0.89 [0.73], P = .05). CONCLUSIONS: The planar configuration of the femtosecond laser flaps is not associated with faster reinnervation compared with the microkeratome flaps. The prolonged decrease in subbasal nerve density after LASIK is not accompanied by a prolonged decrease in corneal sensitivity. TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT00350246.
RCT Entities:
OBJECTIVE: To compare changes in subbasal nerve density and corneal sensitivity after laser in situ keratomileusis (LASIK) with the flap created by a femtosecond laser (bladeless) vs a mechanical microkeratome. DESIGN: In a randomized paired-eye study, 21 patients received myopic LASIK with the flap created by a femtosecond laser in one eye and by a mechanical microkeratome in the fellow eye. Eyes were examined before and at 1, 3, 6, 12, and 36 months after LASIK. Central subbasal nerve density was measured by using confocal microscopy. Corneal mechanical sensitivity was measured by using a gas esthesiometer and was expressed as the ratio of mechanical threshold in eyes that received LASIK to mechanical threshold in concurrent control eyes. RESULTS: Subbasal nerve density and corneal sensitivity did not differ between methods of flap creation at any examination. Mean (SD) nerve density was decreased at 1 month (bladeless, 974 [2453] μm/mm(2); microkeratome, 1308 [2881] μm/mm(2)) compared with the preoperative examination (bladeless, 10,883 [5083] μm/mm(2), P < .001; microkeratome, 12,464 [6683] μm/mm(2), P < .001) and remained decreased through 12 months (P < .001). Mechanical threshold ratios did not differ from that at the preoperative examination through 36 months for either LASIK treatment; when all LASIK eyes were combined, the mechanical threshold ratio was transiently higher (decreased sensitivity) at 1 month (1.29 [0.85]) compared with the preoperative examination (0.89 [0.73], P = .05). CONCLUSIONS: The planar configuration of the femtosecond laser flaps is not associated with faster reinnervation compared with the microkeratome flaps. The prolonged decrease in subbasal nerve density after LASIK is not accompanied by a prolonged decrease in corneal sensitivity. TRIAL REGISTRATION: clinicaltrials.gov Identifier NCT00350246.
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