Purpose: To evaluate efficacy, predictability, stability and safety of adjustable refractive surgery (ARS) by combining a phakic intraocular lens (IOL) (Artisan lens 6-mm optical zone [OZ]) and laser in situ keratomileusis (LASIK) (6.5 mm OZ) for the correction of myopia greater than -15.00 diopters (D).
Design: Noncomparative interventional case series.
Participants: Twenty-six eyes of 18 patients with a preoperative spherical equivalent between -16.00 and -23.00 D.
Methods: First surgery: An 8.5/9.5-mm flap was created and a 6-mm optic iris claw phakic IOL of -15.00 D was inserted in the anterior chamber through a posterior corneal incision. The second surgery was performed once refraction and topography were stable, between 3 and 5 months later. Second surgery: LASIK enhancement (6.5-9.2 OZ); the flap was relifted, and the residual refractive error was corrected.
Main outcome measures: The main parameters in this study were uncorrected visual acuity, best-corrected visual acuity (BCVA), refraction, contrast sensitivity, endothelial cell count (ECC), and subjective response.
Results: Twenty-eight months after both surgeries, 80.70% of the eyes were within 0.50 D of emmetropia and 100% within 1.0 D. Twenty-six percent of the eyes gained 3 or more lines from their preoperative BCVA, and 42% gained 2 or more lines. There was no visual loss in any eye from 6 weeks to 24 months after LASIK enhancement (second surgery) and refraction, and visual acuities remained stable. Two subjects (11%) had some subjective disturbances at night. There was a 0.61% mean loss of ECC during the first 12 months and a 0.60% loss during the next 16 months. No serious complications were observed.
Conclusions: ARS with the combination of a 6-mm optic, 15 D Artisan lens, and LASIK appears to be a safe and highly predictable method for the correction of myopia greater than -15.00 D. It is the best approach with the technology currently available.