Tehrani Mana, Dick H Burkhard
Department of Ophthalmology, Johannes Gutenberg-University, Mainz, Germany.
Ophthalmology. 2005 Dec;112(12):2189-95. doi: 10.1016/j.ophtha.2005.06.036. Epub 2005 Oct 21.
To evaluate efficiency, predictability, stability, complications, and patient satisfaction after implantation of a foldable iris-fixated phakic intraocular lens (PIOL) for the correction of myopia.
Prospective, nonrandomized, comparative (self-controlled) trial.
Forty-one eyes of 22 myopic patients aged 18 to 56 years (mean, 36 years) with average sphere of -8.2+/-2.01 diopters (D; range, -12.25 to -3.75 D) and average preoperative cylinder of -0.90+/-0.62 D (range, -2.50 to 0.00 D) were enrolled in this prospective study.
All eyes underwent implantation of a foldable iris-fixated PIOL with an optical zone of 6.0 mm. The follow-up was 6 months in all cases. Phakic intraocular lenses were available in powers ranging from -2.0 D to -12.0 D.
The main parameters assessed were best spectacle-corrected visual acuity (BSCVA), uncorrected visual acuity, refraction, endothelial cell count, intraocular pressure, slit-lamp biomicroscopy, and indirect ophthalmoscopy.
At 6 months' follow-up, no eyes experienced a loss in BSCVA and 78% gained 1 or more lines of their preoperative BSCVA. Uncorrected visual acuity was significantly improved, with 82% of eyes reaching 20/25 or better. There was a significant reduction in spherical errors in all patients after surgery. Ninety-one percent of eyes were within +/-0.50 D of target refraction. A slight loss of endothelial cells (2.3 %) was observed 6 months after surgery. There were no intraoperative complications. In the postoperative follow-up, however, pigment precipitates were noted in 5 eyes of 4 patients.
At short-term follow-up, the implantation of the foldable iris-fixated PIOL proved to be effective and predictable for the correction of myopia in phakic eyes. However, longer follow-up with larger numbers of patients is necessary to evaluate long-term complications.
评估植入可折叠虹膜固定型有晶状体眼人工晶状体(PIOL)矫正近视后的有效性、可预测性、稳定性、并发症及患者满意度。
前瞻性、非随机、对照(自身对照)试验。
22例年龄在18至56岁(平均36岁)的近视患者的41只眼,平均球镜度数为-8.2±2.01屈光度(D;范围为-12.25至-3.75 D),术前平均柱镜度数为-0.90±0.62 D(范围为-2.50至0.00 D),纳入该前瞻性研究。
所有眼均植入光学区为6.0 mm的可折叠虹膜固定型PIOL。所有病例随访6个月。有晶状体眼人工晶状体的屈光度范围为-2.0 D至-12.0 D。
评估的主要参数包括最佳矫正视力(BSCVA)、裸眼视力、验光、内皮细胞计数、眼压、裂隙灯生物显微镜检查和间接检眼镜检查。
随访6个月时,无眼的BSCVA下降,78%的眼较术前最佳矫正视力提高了1行或更多行。裸眼视力显著改善,82%的眼达到20/25或更好。术后所有患者的球镜误差均显著降低。91%的眼的屈光度数在目标度数±0.50 D范围内。术后6个月观察到内皮细胞略有丢失(2.3%)。术中无并发症。然而,在术后随访中,4例患者的5只眼中发现了色素沉着。
短期随访结果显示,植入可折叠虹膜固定型PIOL矫正有晶状体眼近视有效且可预测。然而,需要对更多患者进行更长时间的随访以评估长期并发症。