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

We report six-month results of the Summit Technology Myopic Keratomileusis Phase I multicenter study. Fifty-seven eyes of 57 patients had keratomileusis to correct high myopia. A microkeratome was used for the primary keratectomy and the excimer laser was used to ablate the stroma 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 uncorrected visual acuity of 20/40 or better; 16 (34.0%) had uncorrected acuity of 20/25 or better. Thirty-seven eyes (78.7%) maintained the same (+/- one Snellen line) best corrected visual acuity as before surgery; seven (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 and six fellow eyes). At six months, 17 of the 24 eyes available for follow-up (70.9%) had uncorrected visual acuity of 20/40 or better and nine (37.5%) had uncorrected acuity of 20/25 or better, including eyes that had worse than 20/80 best corrected visual acuity preoperatively. At 24 months, five of the seven eyes available for follow-up (71.4%) had uncorrected acuity of 20/25 or better. Only one patient lost two lines of best corrected vision at six months and no patient lost more than two lines; at 24 months, all patients maintained (+/- one line) best corrected vision. Our findings suggest that myopic keratomileusis performed with the microkeratome, using the excimer laser for the refractive cut, is a safe, effective, and relatively predictable way to correct high myopia in the 6.0 to 25.0 diopter range. With longer follow-up, the accuracy of the refractive correction, as well as best corrected visual acuity and uncorrected visual acuity, continues to improve.