6-MONTH RESULTS OF THE MULTICENTER PHASE-I STUDY OF EXCIMER-LASER MYOPIC KERATOMILEUSIS

We report six-month results of the Summit Technology Myopic Keratomile usis Phase I multicenter study. Fifty-seven eyes of 57 patients had ke ratomileusis to correct high myopia. A microkeratome was used for the primary keratectomy and the excimer laser was used to ablate the strom a of the resected lenticle (cap) or the stromal bed (in situ). At six months, 31 of the 47 eyes available for follow-up (65.9%) had uncorrec ted visual acuity of 20/40 or better; 16 (34.0%) had uncorrected acuit y of 20/25 or better. Thirty-seven eyes (78.7%) maintained the same (/- one Snellen line) best corrected visual acuity as before surgery; s even (14.9%) lost two lines and three (6.4%) lost more than two lines. In addition to the six-month multicenter study results, we report two year results in a subset of 28 eyes (22 from the multicenter study an d six fellow eyes). At six months, 17 of the 24 eyes available for fol low-up (70.9%) had uncorrected visual acuity of 20/40 or better and ni ne (37.5%) had uncorrected acuity of 20/25 or better, including eyes t hat had worse than 20/80 best corrected visual acuity preoperatively. At 24 months, five of the seven eyes available for follow-up (71.4%) h ad uncorrected acuity of 20/25 or better. Only one patient lost two li nes of best corrected vision at six months and no patient lost more th an two lines; at 24 months, all patients maintained (+/- one line) bes t corrected vision. Our findings suggest that myopic keratomileusis pe rformed with the microkeratome, using the excimer laser for the refrac tive cut, is a safe, effective, and relatively predictable way to corr ect high myopia in the 6.0 to 25.0 diopter range. With longer follow-u p, the accuracy of the refractive correction, as well as best correcte d visual acuity and uncorrected visual acuity, continues to improve.