Comparison of mechanical and femtosecond laser tunnel creation for intrastromal corneal ring segment implantation in keratoconus: prospective randomized clinical trial.

Purpose: To compare the outcomes of mechanical and femtosecond laser-assisted tunnel creation for intrastromal corneal ring segment (ICRS) implantation in eyes with keratoconus.

Setting: Kartal Training and Research Hospital, Istanbul, Turkey.

Methods: In this prospective study, consecutive eyes with keratoconus were randomly assigned to have ICRS tunnel creation with a mechanical device or a femtosecond laser. Keraring ICRS with a 5.0 mm diameter and 160-degree arc length were implanted in all cases. The uncorrected (UDVA) and corrected (CDVA) distance visual acuities, refraction, and keratometry (K) readings were measured preoperatively and 1 year postoperatively, and the data in the mechanical group and the femtosecond group were compared statistically.

Results: One year postoperatively, there was significant improvement in UDVA, CDVA, K readings, spherical equivalent (SE), and manifest sphere and cylinder in both groups (P<.05). The UDVA improved by 2.4 lines in the mechanical group and 2.0 lines in the femtosecond group and the CDVA by 3.3 lines and 2.7 lines, respectively; the mean reduction in maximum keratometry was 4.50 diopters (D) and 4.70 D, respectively, and the mean reduction in SE, 3.18 D and 3.09 D, respectively. There were no statistically significant differences between the 2 groups in visual or refractive results (P>.05). Anterior corneal perforation, superficial segment placement, and segment extrusion occurred in 1 eye each in the mechanical group. Segment migration occurred in 1 eye in the femtosecond group.

Conclusion: Despite intraoperative complications in the mechanical group, the visual and refractive outcomes were similar to those in the femtosecond group.