Purpose: To evaluate the effectiveness, predictability, and safety of a fourth-generation angle-supported anterior chamber phakic intraocular lens (IOL) in patients with severe myopia.
Setting: Refractive Surgery and Cornea Unit, Alicante Institute of Ophthalmology, Miguel Hernández University School of Medicine, Alicante, Spain.
Methods: In this prospective study, 23 eyes (16 patients) with a mean preoperative myopia of -19.56 diopters (D) +/- 1.76 (SD) (range -16.75 to -23.25 D) were implanted with the ZSAL-4 phakic IOL. Basic examinations were performed before and after surgery in all patients. Eighteen eyes were also studied by clinical specular microscopy, and the endothelium was analyzed for cell density, coefficient of variation in cell size, and hexagonality. The location of the IOL in the anterior chamber was evaluated in 10 eyes by A-scan biometry. To evaluate haptic geometry, a theoretical mechanical model was used. The follow-up was 24 months in all patients.
Results: Uncorrected visual acuity was 20/40 or better in 13 eyes (56.0%) 12 months after surgery and in 14 eyes (60.8%) at 24 months. Best spectacle-corrected visual acuity improved 0.19 at 12 and 24 months (0.1 = 1 line) from preoperative values. The efficacy index was 1.12 at 24 months and the safety index, 1.45. The mean postoperative spherical equivalent was -0.65 +/- 0.65 D at 24 months. The postoperative spherical equivalent was within +/-1.00 D of emmetropia in 19 eyes (82.6%) at 12 and 24 months. The mean endothelial cell loss was 3.50% at 12 months and 4.18% at 24 months. The coefficient of variation in cell size decreased from 0.34 before surgery to 0.28 at 24 months after surgery. The IOL was located 0.79 +/- 0.24 mm in front of the crystalline lens. Postoperative complications included night halos in 6 eyes (26.1%) at 12 and 24 months and pupil ovalization in 4 eyes (17.4%). Intraocular lens rotation was observed in 10 eyes (43.5%) at 24 months. Two eyes (8. 7%) developed a slight inflammatory response during the first 6 months. Our mechanical model predicted that the compression forces against the angle structures were greater at the first footplate than at the second.
Conclusions: Implantation of the ZSAL-4 IOL in the anterior chamber of phakic eyes was effective and predictable in correcting severe myopia. However, the ZSAL-4 did not prevent pupil ovalization, IOL rotation, or low-grade postoperative uveitis. Improvements in haptic design following our mechanical model could decrease these haptic-related complications.