Alió J L, de la Hoz F, Pérez-Santonja J J, Ruiz-Moreno J M, Quesada J A
Instituto Oftalmológico de Alicante, Spain.
Ophthalmology. 1999 Mar;106(3):458-66. doi: 10.1016/S0161-6420(99)90103-3.
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.
Nonrandomized, prospective, comparative trial.
Two hundred sixty-three eyes of 160 consecutive patients were included.
Angle-supported anterior chamber intraocular lenses were implanted into phakic eyes.
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.
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.
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.
进行一项前瞻性临床试验，以确定植入有晶状体眼人工晶状体（PIOL）矫正近视患者的潜在累积并发症。
非随机、前瞻性、对照试验。
纳入160例连续患者的263只眼。
将有晶状体眼前房人工晶状体植入有晶状体眼中。
记录夜间光晕和眩光情况。由同一位医生记录中央内皮细胞计数、术后炎症、压平眼压测量、白内障进展、视网膜脱离及瞳孔椭圆化情况。
随访1年时，20.2%的患者报告有明显夜间光晕和眩光，随访7年时为10%。大光学区PIOL（ZSAL-4）组的这种并发症明显低于ZB5M/ZB5MF组（P<0.05）。4.56%的病例观察到急性术后虹膜炎。7.2%的病例出现需要抗青光眼药物治疗的高眼压。术后3个月中央角膜内皮细胞密度显著降低（P<0.0001）。细胞丢失率在术后3个月为3.76%，1年时为1.83%，随后在2年时再降低1.37%，3年时为0.72%，4年时为0.3%，5年时为0.6%，6年时为0.4%，7年时为0.56%。7年后中央内皮细胞的总累积丢失率为8.37%。5.9%的病例存在瞳孔椭圆化，另有10.3%的病例观察到程度较轻的这种并发症。3%的病例出现视网膜脱离。因白内障进展（9例）和与严重眩光相关的极度瞳孔椭圆化（2例），11例（4.18%）患者决定取出PIOL。Kaplan-Meier累积生存分析研究显示，眼压升高并发症的预期无并发症期为86.5%，内皮细胞计数低于1500个细胞/mm²的预期无并发症期为98.75%，瞳孔椭圆化的预期无并发症期为86.97%，视网膜脱离的预期无并发症期为95.43%，取出PIOL的预期无并发症期为89.02%。
有晶状体眼人工晶状体似乎能被角膜内皮良好耐受，其他并发症发生率较低。瞳孔椭圆化似乎是这类有晶状体眼人工晶状体的一个特殊问题。
