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.