Aim To assess the early clinical outcomes of an ICL with a central hole (Hole ICL) implantation for the correction of moderate to high myopia. Methods This study evaluated 20 eyes of 20 patients with spherical equivalents of À7.3662.13 D (mean6SD) who underwent Hole ICL implantation. Before surgery and at 1 week and 1, 3 and 6 months after surgery, we assessed the safety, efficacy, predictability, stability and adverse events of the surgery. Results Logarithm of the minimum angle of resolution (logMAR) uncorrected visual acuity and logMAR best spectacle-corrected visual acuity were À0.2060.12 and À0.2560.06, respectively, 6 months after surgery. The safety and efficacy indices were 1.1360.24 and 1.0360.30, respectively. At 6 months, 95%, and 100% eyes were within 60.5 and 61.0 D of the targeted correction, respectively. Change in manifest refraction from week 1 to month 6 was 0.0660.28 D. No significant rise in intraocular pressure (including pupillary block) or a secondary cataract occurred in any case during the period of observation. Conclusions Implantation of a newly developed Hole ICL offered good results for all measures of safety, efficacy, predictability and stability for the correction of moderate to high myopic errors, even without peripheral iridectomy, suggesting its viability as a surgical option for the treatment of such eyes.

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BackgroundWe calculated the smallest diameter of a hole in the center of the optic at which the optical character of a phakic IOL (ICL) may be maintained. The changes induced in the aqueous humor dynamics and the pathology of cataract development with such a hole were investigated.MethodsA simulation was performed using ZEMAX software to calculate the hole diameter that makes possible the maintenance of a stable optical character of a phakic IOL. After a hole of calculated diameter was trepanned in the center of the optic of the ICL, the latter was implanted into one eye of a 5-month-old minipig, and an unperforated ICL into the other. The postoperative course was observed for 3 months. Then, Evans blue was injected into the vitreous body under general anesthesia to stain the anterior capsule of the crystalline lens. Within 30 min, the eye was enucleated and the tissues removed were fixed.ResultsThe MTF of the perforated ICL (hole diameter, 1.0 mm) in the center of the optic resembled that of the unperforated ICL. In all cases with non-perforated ICLs, subcapsular turbidity developed, but no staining caused by EB was observed in the anterior capsule. On the other hand, the anterior capsules of the eyes fitted with ICLs with a 1.0-mm hole were stained, but exhibited no turbidity.ConclusionAn ICL with a central hole of diameter 1.0 mm in the optic is similar to an unperforated ICL. The size of the hole influenced the aqueous humor dynamics and increased the aqueous humor perfusion volume over the entire anterior surface of the crystalline lens. The possibility of preventing cataracts was therefore suggested.

Both SB and PPV gave excellent primary and final anatomical success rates. The macula-off status was associated with a lower success rate in the SB group, although break location and lens status had no significant effect on success rates in either group.