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To evaluate the predictability, stability, safety, and efficacy of the Toric V4c Visian Implantable Collamer Lens (ICL) with central hole to correct moderate to high astigmatism.
Sixty five (65) eyes of 40 patients were evaluated after implantation of the toric V4c ICL. The refraction, best corrected visual acuity (BCVA), uncorrected visual acuity (UCVA), vault, and adverse effects were evaluated throughout 12-months.
The mean spherical equivalent dropped from -6.30 ± 3.79 D (Diopters) preoperatively to -0.15 ± 0.32 D postoperatively, with 90.8% eyes being within ±0.50 D of the desired refraction. The mean refractive cylinder components dropped from J0 = 0.67 ± 0.82 D to J0 = 0.06 ± 0.13 D, and J45 = 0.12 ± 0.65 D to J45 = -0.01 ± 0.15 D. At 12-months, the mean logMAR BCVA was -0.03 ± 0.04, the mean logMAR UCVA was -0.03 ± 0.04, and 36.9 % of eyes gained 1 or more lines of BCVA. Safety and efficacy indexes (with decimal visual acuities) were 1.07 and 1.06, respectively. No intraoperative complications were reported. Two ICLs required an exchange because their length were too short.
The visual and refractive outcomes were very good and highly stable throughout the follow-up period, showing that this toric ICL model may be predictable, stable, safe, and effective to correct moderate to high astigmatism.