Purpose: To evaluate the safety, efficacy, predictability, and stability of phakic refractive lens (PRL) implantation for the correction of super-high myopia.
Methods: This four-center prospective clinical study included 30 eyes from 16 myopic patients who underwent PRL implantation. The patients were followed up for one year, with evaluations of uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), refraction, intraocular pressure (IOP), vault, endothelial cell density (ECD), and axial length.
Results: One year postoperatively, eight eyes (27%) achieved a UDVA of 20/20 or better, and 21 eyes (70%) achieved a UDVA of 20/25 or better. The CDVA improved by one line in 22 eyes (73%), with one eye experiencing a loss of CDVA. The mean efficacy and safety index at one year were 1.30 ± 0.49 and 1.61 ± 0.32, respectively. No significant change was observed in the mean refractive spherical equivalent between one week and one year postoperatively. The axial length remained stable pre- and postoperatively. IOP increased significantly at 1 d and 1 week postoperatively (p = 0.002 and p < 0.001, respectively) but returned to preoperative levels by 1 month. ECD showed no significant change pre- and postoperatively except that 5 eyes from 4 patients had a postoperative ECD below 2000 cells/mm2 caused by surgical trauma. The mean vault was 393.05 ± 243.54 µm at one week and 385.68 ± 157.41 µm at one year, showing no significant change.
Conclusion: PRL implantation for correction of super-high myopia demonstrated good safety, efficacy, predictability, and stability.
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