Department of Ophthalmology, Jinling Hospital, School of Medicine, Nanjing University, Jiangsu, China.
Eye (Lond). 2012 Feb;26(2):321-6. doi: 10.1038/eye.2011.292. Epub 2011 Dec 2.
To evaluate the 5-year follow-up of safety, efficacy, predictability, stability, and complications of anterior iris-fixated phakic intraocular lens (pIOL) implantation to correct high myopia, and patients' satisfaction after implantation.
Prospective, nonrandomized, and comparative (self-controlled) trial.
A prospective clinical trial of 84 eyes of 43 patients with high myopia was conducted. Uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), refraction, endothelial cell count, intraocular pressure (IOP), anterior chamber depth, slit lamp biomicroscopy, and indirect ophthalmoscope were measured preoperatively and postoperatively.
At the 5-year follow-up, UCVA was significantly improved, with 85.7% of eyes reaching 20/25 or better. No eyes experienced a loss in BSCVA, and 71.4% gained one or more lines of their preoperative BSCVA. There was a significant reduction in spherical errors in all patients after operation. Loss of endothelial cells was observed 3 years after operation and no more loss was observed 4 years after operation in statistical analysis. No increase in IOP was observed 5 years after operation in statistical analysis. No intraoperative complications were observed in this study. However, pigment precipitates of varying intensities on the lens optic were noted in all patients 1 day after operation, and only five eyes were observed to have the pigment residual five years after operation.
At the 5-year follow-up, the implantation of the anterior iris-fixated pIOL was proved to be effective, predictable and capable of reversibility to correct high myopia in phakic eyes. It was a safety addition to the laser refractive surgery. However, longer follow-up with larger numbers of patients is still necessary to evaluate long-term complications.
评估前房型虹膜固定型有晶状体眼人工晶状体(pIOL)矫正高度近视的 5 年安全性、有效性、预测性、稳定性和并发症,以及植入后的患者满意度。
前瞻性、非随机、对照(自身对照)试验。
对 43 例 84 只高度近视患者进行前瞻性临床研究。术前和术后分别测量未矫正视力(UCVA)、最佳矫正视力(BSCVA)、屈光度、内皮细胞计数、眼压(IOP)、前房深度、裂隙灯生物显微镜和间接检眼镜。
5 年随访时,UCVA 明显提高,85.7%的眼达到 20/25 或更好。无眼视力丧失,71.4%的眼获得术前 BSCVA 提高一行或更多行。所有患者术后球镜屈光度均显著降低。术后 3 年观察到内皮细胞丢失,术后 4 年统计学分析未见进一步丢失。术后 5 年统计学分析未见 IOP 升高。本研究未观察到术中并发症。然而,所有患者术后 1 天均观察到晶状体光学上有不同强度的色素沉着,5 年后仅 5 只眼观察到色素残留。
5 年随访证实,前房型虹膜固定型 pIOL 植入术可有效、可预测地矫正有晶状体眼高度近视,并具有可逆性,是激光屈光手术的安全补充。然而,仍需要更长时间的随访和更多数量的患者来评估长期并发症。