Phakic anterior chamber lenses for the correction of myopia - A 7-year cumulative analysis in complications in 283 cases

Objective: To perform a prospective, clinical trial to determine the potent ial cumulative complications of patients implanted with angle-supported pha kic 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 impl anted into phakic eyes. Main Outcome Measures: Night halos and glare were recorded. Central endothe lial cell count, postoperative inflammation, applanation tonometry, catarac t development, retinal detachment, and pupil ovalization were recorded by t he same physician. Results: Night halos and glare were reported as significant by 20.2% at 1 y ear and 10% at year 7 of follow-up. This complication was significantly low er 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 i ntraocular pressure that required antiglaucoma medications appeared in 7.2% of cases. Central corneal endothelial cell density was significantly decre ased at postoperative month 3 (P < 0.0001). The percentages of cell loss we re 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 e ndothelial 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 expl antation was decided in 1 1 cases (4.18 %) because of cataract development (9 cases) and extreme pupil ovalization associated with severe glare (2 cas es). The Kaplan-Meier cumulative survival analysis study showed an expected period free from complication of 86.5% for IOP elevation, 98.75% for endot helial cell count inferior to 1500 cells/mm(2), 86.97% for pupil ovalizatio n, 95.43% for retinal detachment, and 89.02% for explantation. Conclusions: Angle-supported PIOL appeared to be well tolerated by the corn eal endothelium with a low rate of other complications. Pupil ovalization s eemed to be a specific problem for this type of PIOL.