Intrastromal femtosecond laser presbyopia correction: 1-year results of a multicenter study.

ABSTRACT

PURPOSE: To investigate functional outcomes of the INTRACOR femtosecond laser-based intrastromal procedure to treat presbyopia. METHODS: Sixty-three eyes from 63 presbyopic patients (median age 54 years) with mild hyperopia were enrolled in this prospective, ethics committee-approved, multi-center, nonrandomized clinical trial. The INTRACOR procedure was performed using the Technolas femtosecond laser (Technolas Perfect Vision GmbH) in the nondominant eye. Postoperatively, follow-up was performed at 1 day, 1 week, and 1, 3, 6, and 12 months and included near and distance visual acuity tests, slit-lamp examinations, and corneal topography. RESULTS: All 63 surgeries were uneventful. Twelve months postoperatively, outcomes of 58 (92.1%) eyes were available for evaluation. Median uncorrected distance visual acuity (0.1 logMAR [range 0.5 to 0.0 preoperatively and 0.5 to -0.1 postoperatively]) and corrected distance visual acuity (CDVA) (0.0 logMAR [range 0.2 to -0.2 preoperatively and 0.3 to -0.1 postoperatively]) remained stable. Median spherical equivalent changed from +0.63 diopters (D) preoperatively to 0.00 D postoperatively. Median uncorrected near visual acuity increased significantly from 0.7 logMAR (range 1.0 to 0.2) preoperatively to 0.2 logMAR (range 0.8 to -0.1) postoperatively and eyes gained a median of 4 lines (range 1 to 9 lines). Losses of 2 lines of CDVA were noted in 7.1% of eyes. Ring cuts were faintly visible at 12 months. CONCLUSIONS: The INTRACOR presbyopia procedure showed good and stable visual acuity outcomes over 12-month follow-up but loss of CDVA occurred in 7% of eyes. Overall patient satisfaction with the procedure was approximately 80%. Short treatment time and maintained corneal surface integrity are advantages of this procedure.