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ABSTRACT: To evaluate the effectiveness, safety and predictability of the phakic intraocular lens (IOL) ZSAL-4 for correction of high myopia. In this retrospective study 28 IOL in 19 patientes were implanted. The following data were recorded, preoperatively, one week, one month, 3, 6 and 12 months postoperatively: spherical equivalent (SE), astigmatism, uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), endothelial cell density (CD), coefficient of variation (CV) and intraocular pressure (IOP). We performed LASIK in 3 eyes to correct a residual refractive defect. The mean age was 29.7 S.D. 5.77 years and the mean following 7.62 S.D. 7.29 months. Six months postoperatively, the preoperative SE of -14.91 S.D. 2.88 was reduced to -1.29 S.D. 0.53; the BCVA varied from 0.56 S.D. 0.16 to 0.58 S.D. 0.12; the CD changed from 2670 S.D. 252 cells/mm2 to 2344 S.D. 262. The CV showed stability. The UCVA six months postoperatively was 0.39 S.D. 0.15. No eyes lost any line of BCVA; during the first month 63% of the eyes won 2 or more lines. The efficacy index was 0.83 S.D. 0.24 one month postoperatively and 0.63 S.D. 0.32 one year postoperatively; the safety index was 1.44 D.S. 0.34 and 1.30 S.D. 0.35 respectively. One IOL was explanted the second day due to pupilary blockage; 7 eyes had transient high IOP; 2 eyes developed pupilary ovalization and in 4 cases the IOL suffered some degree of rotation. One eye presented a flat retinal detachment one year postoperatively but with no other complications. The 3 eyes submitted to LASIK presented 0.8 of BCVA the third month after LASIK. ZSAL-4 IOL implantation is an effective and safe procedure with an acceptable predictability which, in some cases, could be improved with LASIK.Archivos de la Sociedad Espanola de Oftalmologia 01/2003; 77(12):661-7.