Phakic anterior chamber lenses for the correction of myopia: a 7-year cumulative analysis of complications in 263 cases.

OBJECTIVE To perform a prospective, clinical trial to determine the potential cumulative complications of patients implanted with angle-supported phakic intraocular lenses (PIOLs) for the correction of myopia. DESIGN Nonrandomized, prospective, comparative trial. PARTICIPANTS Two hundred sixty-three eyes of 160 consecutive patients were included. INTERVENTION Angle-supported anterior chamber intraocular lenses were implanted into phakic eyes. MAIN OUTCOME MEASURES Night halos and glare were recorded. Central endothelial cell count, postoperative inflammation, applanation tonometry, cataract development, retinal detachment, and pupil ovalization were recorded by the same physician. RESULTS Night halos and glare were reported as significant by 20.2% at 1 year and 10% at year 7 of follow-up. This complication was significantly lower in the larger optical zone PIOL (ZSAL-4) than in the ZB5M/ZB5MF group (P < 0.05). Acute postoperative iritis was observed in 4.56% of cases. High intraocular pressure that required antiglaucoma medications appeared in 7.2% of cases. Central corneal endothelial cell density was significantly decreased at postoperative month 3 (P < 0.0001). The percentages of cell loss were 3.76% at month 3 and 1.83% at year 1, and then the percentages decreased by 1.37% more at year 2, 0.72% at year 3, 0.3% at year 4, 0.6% at year 5, 0.4% at year 6, and 0.56% at year 7. The total cumulative loss of central endothelial cells after 7 years was 8.37%. Pupil ovalization was present in 5.9% of cases, although smaller degrees of this complication were observed in another 10.3%. Retinal detachment appeared in 3% of cases. The PIOL explantation was decided in 11 cases (4.18%) because of cataract development (9 cases) and extreme pupil ovalization associated with severe glare (2 cases). The Kaplan-Meier cumulative survival analysis study showed an expected period free from complication of 86.5% for IOP elevation, 98.75% for endothelial cell count inferior to 1500 cells/mm2, 86.97% for pupil ovalization, 95.43% for retinal detachment, and 89.02% for explantation. CONCLUSIONS Angle-supported PIOL appeared to be well tolerated by the corneal endothelium with a low rate of other complications. Pupil ovalization seemed to be a specific problem for this type of PIOL.

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